A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

• ClinicalTrials.gov Identifier: NCT02499497
• Recruitment Status: Completed
• First Posted: July 16, 2015
• Results First Posted: September 28, 2021
• Last Update Posted: September 28, 2021
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Shalender Bhasin, MD, Dana-Farber Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Prostate Cancer
• Interventions: Drug: LY2452473; Drug: Placebo
• Enrollment: 114

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. N-[(2S)-7-cyano-1,2,3,4-tetrahydro-4-(2-pyridinylmethyl)cyclopent[b]indol-2-yl]-,1-methylester (LY2452473): LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Period Title: Overall Study
Started	36	28	36	14
Completed	32	22	35	13
Not Completed	4	6	1	1

Baseline Characteristics

Arm/Group Title		Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3	Total
Arm/Group Description		Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	Total of all reporting groups
Overall Number of Baseline Participants		36	28	36	14	114
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	36 participants	28 participants	36 participants	14 participants	114 participants
		67.1 (6.1)	67.1 (7.87)	67.4 (8.6)	69.6 (7.1)	67.5 (7.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	36 participants	28 participants	36 participants	14 participants	114 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	36 100.0%	28 100.0%	36 100.0%	14 100.0%	114 100.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants	0 participants	0 participants
						0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	36 participants	28 participants	36 participants	14 participants	114 participants
		36 100.0%	28 100.0%	36 100.0%	14 100.0%	114 100.0%
Weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	36 participants	28 participants	36 participants	14 participants	114 participants
		84.9 (12.7)	92.7 (10.7)	89.7 (15.4)	86.7 (12.5)	88.5 (13.4)
Body Mass Index (BMI); Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	36 participants	28 participants	36 participants	14 participants	114 participants
		27.9 (3.8)	29.8 (3.89)	29.3 (4.1)	29.2 (5.1)	29.0 (4.1)
Short Physical Performance Battery (SPPB) score [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	36 participants	28 participants	36 participants	14 participants	114 participants
		11.4 (1.15)	11.1 (1.21)	11.1 (1.42)	11.1 (1.07)	11.2 (1.24)
		[1] Measure Description: The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. The scores range from 0 to 12. The higher the score, the better the performance.

Outcome Measures

1. Primary Outcome

Title	Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
Description	The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	28	23	35	13
Mean (Standard Error); Unit of Measure: units on a scale
	0.04 (0.19)	0.45 (0.26)	-0.02 (0.22)	0.12 (0.27)

2. Secondary Outcome

Title	Change in All Domains of International Index of Erectile Function (IIEF)
Description	IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	12
Mean (Standard Error); Unit of Measure: units on a scale
Erectile Function	2.34 (1.02)	0.92 (0.48)	-0.50 (0.94)	3.38 (2.83)
Intercourse satisfaction	0.97 (0.50)	0.42 (0.25)	-0.22 (0.39)	0.92 (1.59)
Orgasmic function	0.12 (0.48)	0.17 (0.32)	-0.53 (0.57)	0.75 (0.85)
Sexual desire	0.30 (0.22)	0.46 (0.38)	-0.19 (0.25)	0.83 (0.61)
Overall satisfaction	1.13 (0.34)	0.79 (0.32)	0.31 (0.33)	0.25 (0.70)
Composite IIEF	4.79 (1.96)	2.73 (1.28)	-1.22 (1.90)	6.14 (5.90)

3. Secondary Outcome

Title	Change in Sexual Activity, Interest, and Desire Scale (SAID)
Description	The Sexual Activity, Interest, and Desire Scale (SAID) is an 8-item questionnaire that evaluates 3 response domains, including sexual thinking, sexual arousal, and sexual activity. The score was linearly transformed to a 0 to 100 scale for each item. The average score ranges 0-100. The higher the score, the better the sexual function.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	12
Mean (Standard Error); Unit of Measure: units on a scale
	-0.67 (2.36)	4.25 (2.85)	-3.00 (3.27)	-1.50 (4.67)

4. Secondary Outcome

Title	Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Description	Derogatis Index of Sexual Function Male II (DISF-M-II) is a 25-item questionnaire that provides an estimate of perceived quality of sexual activities in 5 response domains: sexual desire/drive (range 0-33), sexual arousal (range 0-33), sexual activity (range 0-35), orgasm (range 0-26), and sexual satisfaction/partner relationship (range 0-25). The total possible score (sum of 5 domains) range of 0 to 152 with higher scores representing better function.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	23	36	12
Mean (Standard Error); Unit of Measure: units on a scale
Sexual Desire	-0.88 (0.89)	0.87 (1.63)	-0.81 (0.97)	1.08 (2.21)
Sexual Arousal	0.45 (0.62)	0.83 (0.74)	0.00 (0.74)	0.67 (0.94)
Sexual Activity	-0.33 (0.65)	0.96 (0.81)	0.53 (0.67)	0.67 (0.83)
Orgasm	0.55 (0.82)	0.57 (0.84)	-0.31 (0.77)	0.75 (2.07)
Sexual Satisfaction	0.27 (0.69)	1.22 (1.18)	0.22 (0.91)	1.42 (1.69)
Composite DISF-M-II	0.06 (2.70)	4.43 (3.91)	-0.36 (3.26)	4.58 (5.98)

5. Secondary Outcome

Title	Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Description	Men's Sexual Health Questionnaire (MSHQ), a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). Erection, Ejaculation and Satisfaction domains were measured and the higher score representing better sexual function and satisfaction.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title		Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:		Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed		33	24	36	13
Mean (Standard Error); Unit of Measure: units on a scale
Erection	Number Analyzed	30 participants	20 participants	34 participants	10 participants
		0.80 (0.36)	0.80 (0.52)	-0.65 (0.48)	1.30 (0.45)
Ejaculation	Number Analyzed	32 participants	21 participants	35 participants	11 participants
		1.34 (1.15)	2.38 (1.72)	-1.46 (1.16)	-1.55 (3.26)
Satisfaction	Number Analyzed	33 participants	21 participants	30 participants	11 participants
		1.03 (0.58)	0.98 (0.85)	-0.40 (0.84)	1.27 (1.05)

6. Secondary Outcome

Title	Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
Description	Expanded Prostate Cancer Index Composite (EPIC) is a 50-item, comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Of its four domains, the sexual domain (range 0-100) and hormonal domain (range 0-100) were utilized. The response for each item is standardized to a 0 to 100 scale. Higher score yields better quality of life.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title		Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:		Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed		33	24	36	13
Mean (Standard Error); Unit of Measure: units on a scale
Sexual function	Number Analyzed	32 participants	24 participants	34 participants	12 participants
		1.86 (2.14)	3.68 (3.04)	0.08 (2.52)	5.77 (3.90)
Hormonal function	Number Analyzed	33 participants	24 participants	35 participants	12 participants
		1.24 (1.06)	0.44 (2.04)	0.52 (1.22)	6.25 (5.79)

7. Secondary Outcome

Title	Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Description	The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: units on a scale
	0.31 (1.30)	2.29 (1.36)	-0.36 (1.28)	0.26 (1.47)

8. Secondary Outcome

Title	Change in Hypogonadism Energy Diary (HED)
Description	Hypogonadism Energy Diary (HED) is a 4-item questionnaire that intended to assess real-time energy levels. Score ranges 0 to100 with higher scores representing higher energy. each question uses an 11-point numerical rating scale (0-10) with 10 corresponding to full of energy or extreme tiredness. HED score was the average of the scores for these 4 items. Scores were linearly transformed to a 0 to 100 scale. Higher scores representing higher energy.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: units on a scale
	-0.45 (2.78)	2.71 (2.82)	2.64 (3.42)	1.73 (5.07)

9. Secondary Outcome

Title	Change in International Prostate Symptom Score (IPSS)
Description	International Prostate Symptom Score (IPSS) is a 8-item, extensively validated and widely used self-reported measure of lower urinary tract symptoms questionnaire. It includes Urinary Symptoms (item1-7, range 0-35) and Quality of Life Due to Urinary Symptoms (item 8, range 0-6). The higher the score, the severer of the urinary symptoms and worse quality of life due to symptoms.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title		Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:		Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed		33	24	36	13
Mean (Standard Error); Unit of Measure: units on a scale
Urinary Symptoms	Number Analyzed	33 participants	24 participants	36 participants	13 participants
		-0.30 (0.59)	-2.08 (0.65)	0.06 (0.48)	0.00 (0.62)
Quality of Life Due to Urinary Symptoms	Number Analyzed	32 participants	24 participants	35 participants	13 participants
		-0.13 (0.13)	-0.17 (0.17)	-0.03 (0.18)	-0.15 (0.19)

10. Secondary Outcome

Title	Change in Positive and Negative Affect Scale (PANAS)
Description	The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Score ranges 10-50 for both positive and negative affect. The higher scores represent higher levels of positive/negative affect.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: units on a scale
Positive Affect	0.91 (0.89)	0.75 (1.84)	1.42 (1.03)	-0.77 (0.89)
Negative Affect	-1.70 (0.72)	-1.38 (0.58)	0.42 (0.58)	-2.77 (1.49)

11. Secondary Outcome

Title	Change in Body Mass Using DXA
Description	Whole body, appendicular, and trunk lean mass were measured using dual energy X- ray absorptiometry (DXA), calibrated using a soft tissue phantom before each scan.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	32	24	34	13
Mean (Standard Error); Unit of Measure: kg
Appendicular Fat Mass	-0.06 (0.11)	-0.19 (0.10)	-0.36 (0.11)	-0.13 (0.11)
Trunk Fat Mass	-0.00 (0.14)	-0.32 (0.18)	-0.38 (0.16)	-0.72 (0.19)
Total Fat Mass	-0.05 (0.22)	-0.52 (0.24)	-0.75 (0.22)	-0.86 (0.27)
Appendicular Lean Mass	-0.04 (0.10)	0.15 (0.13)	0.80 (0.13)	1.05 (0.23)
Trunk Lean Mass	0.22 (0.12)	0.20 (0.19)	0.68 (0.19)	0.88 (0.26)
Total Lean Mass	0.20 (0.16)	0.33 (0.27)	1.48 (0.28)	1.92 (0.42)

12. Secondary Outcome

Title	Change of Maximal Voluntary Muscle Strength
Description	The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	17	10	18	7
Mean (Standard Error); Unit of Measure: N
	-12.6 (55.0)	108.1 (56.8)	48.1 (29.4)	103.5 (37.1)

13. Secondary Outcome

Title	Change in Gait Speed in 6-minute Walk
Description	Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	28	20	31	10
Mean (Standard Error); Unit of Measure: m/sec
	0.05 (0.02)	0.07 (0.02)	0.08 (0.02)	0.05 (0.03)

14. Secondary Outcome

Title	Change of 50 Meters Walk Tests- Unloaded /Loaded
Description	Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. One test consisted of walking 50 meters as rapidly as possible without running (unloaded) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags(loaded). Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title		Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:		Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed		28	21	32	11
Mean (Standard Error); Unit of Measure: m/sec
Unloaded	Number Analyzed	28 participants	21 participants	28 participants	10 participants
		0.06 (0.03)	0.12 (0.04)	0.03 (0.02)	0.07 (0.06)
Loaded	Number Analyzed	21 participants	16 participants	20 participants	9 participants
		0.05 (0.03)	0.13 (0.05)	0.05 (0.04)	0.09 (0.05)

15. Secondary Outcome

Title	Change in Power of Stair Climbing Tests- Unloaded/Loaded
Description	Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title		Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:		Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed		28	21	32	11
Mean (Standard Error); Unit of Measure: watts
Unloaded	Number Analyzed	24 participants	15 participants	22 participants	7 participants
		12.8 (26.1)	19.7 (19.6)	1.8 (15.6)	51.7 (21.9)
Loaded	Number Analyzed	18 participants	10 participants	11 participants	5 participants
		0.22 (24.89)	-36.6 (24.9)	-9.8 (21.5)	59.4 (42.3)

16. Secondary Outcome

Title	Change in Serum Total Testosterone Level
Description	Serum total testosterone levels during screening was measured in the Quest Diagnostics Laboratory, Chantilly, VA, using liquid chromatography tandem mass spectrometry (LC-MS/MS) method certified by the Hormone Standardization Program for Testosterone (HoST) of the Centers for Disease Control and Prevention, Atlanta, Georgia.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: ng/dL
	-6.5 (15.8)	-83.5 (21.3)	-172.3 (27.6)	-185.2 (46.0)

17. Secondary Outcome

Title	Change in Free Testosterone Level
Description	Free testosterone level for screening was measured using an equilibrium dialysis method.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	32	22	35	13
Mean (Standard Error); Unit of Measure: pg/mL
	0.19 (0.15)	0.59 (0.18)	1.43 (0.20)	1.62 (0.41)

18. Secondary Outcome

Title	Change in Serum Sex Hormone-binding Globulin (SHBG) Level
Description	Serum SHBG level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 2.5 nmol/L, and coefficients of variation less than 10% in low, medium and high range
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	30	21	35	13
Mean (Standard Error); Unit of Measure: nmol/L
	0.6 (1.0)	-9.6 (1.3)	-21.7 (2.1)	-24.2 (5.5)

19. Secondary Outcome

Title	Change in Serum Luteinizing Hormone (LH) Level
Description	Serum LH level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 0.1 U/L, and coefficients of variation less than 10% in low, medium and high range
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	32	22	35	13
Mean (Standard Error); Unit of Measure: mIU/mL
	0.23 (0.27)	0.11 (0.23)	0.72 (1.27)	-0.42 (0.47)

20. Secondary Outcome

Title	Change in Estradiol Levels
Description	Estradiol level was measured by LC-MS/MS.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	32	22	35	13
Mean (Standard Error); Unit of Measure: pg/mL
	-0.2 (1.5)	-1.1 (1.1)	-5.5 (1.1)	-7.9 (2.1)

21. Secondary Outcome

Title	Change of White Blood Cell
Description	White Blood Cell was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: K/uL
	-0.24 (0.15)	0.30 (0.29)	-0.21 (0.19)	0.32 (0.20)

22. Secondary Outcome

Title	Change of Red Blood Cell
Description	Red Blood Cell was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: K/uL
	-0.08 (0.04)	-0.05 (0.05)	0.03 (0.03)	0.06 (0.08)

23. Secondary Outcome

Title	Change in Hematocrit
Description	Hematocrit was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: percentage of volume of red cells
	-0.61 (0.33)	-0.30 (0.51)	0.44 (0.25)	0.11 (0.89)

24. Secondary Outcome

Title	Change in Hemoglobin
Description	Hemoglobin was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: g/dL
	-0.32 (0.11)	-0.12 (0.16)	0.09 (0.09)	-0.01 (0.25)

25. Secondary Outcome

Title	Change of Mean Corpuscular Volume (MCV)
Description	Mean corpuscular volume was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: fL
	0.32 (0.30)	0.44 (0.48)	0.37 (0.31)	-1.08 (0.84)

26. Secondary Outcome

Title	Change of Red Blood Cell Distribution Width (RDW)
Description	Red blood cell distribution width (RDW) was measured for safety monitoring. RDW was calculated with: standard deviation of the mean cell size divided by the mean corpuscular volume of the red cells multiplied by 100
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: percentage of variation of red cells
	0.09 (0.14)	-0.15 (0.22)	0.18 (0.10)	-0.44 (0.29)

27. Secondary Outcome

Title	Change in Platelet Count
Description	Platelet count was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: K/uL
	0.67 (4.61)	6.54 (5.13)	13.5 (4.9)	28.7 (4.1)

28. Secondary Outcome

Title	Change of Aspartate Aminotransferase (AST)
Description	Aspartate aminotransferase was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: U/L
	-1.24 (0.67)	-1.25 (0.81)	2.33 (0.82)	4.46 (2.03)

29. Secondary Outcome

Title	Change of Alanine Aminotransferase (ALT)
Description	Alanine aminotransferase was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: U/L
	-1.36 (0.89)	-3.46 (1.51)	1.28 (1.37)	5.46 (3.35)

30. Secondary Outcome

Title	Change of Total Bilirubin
Description	Total Bilirubin was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: mg/dL
	-0.13 (0.03)	-0.02 (0.03)	-0.16 (0.05)	-0.18 (0.04)

31. Secondary Outcome

Title	Change in Serum Alkaline Phosphatase
Description	Serum alkaline phosphatase was measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: U/L
	-2.94 (1.45)	-2.83 (1.55)	-8.97 (1.44)	-14.1 (3.2)

32. Secondary Outcome

Title	Change of Lipid Panel
Description	Plasma lipids were measured for safety monitoring.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	35	13
Mean (Standard Error); Unit of Measure: mg/dL
Total Cholesterol	-7.55 (2.53)	-15.1 (5.8)	-13.4 (4.5)	-14.9 (7.9)
HDL	-2.55 (1.18)	-4.38 (1.21)	-12.6 (1.3)	-14.6 (3.0)
LDL	-6.00 (2.10)	-7.13 (5.44)	0.57 (4.05)	3.92 (6.94)
Triglycerides	9.36 (8.66)	-23.5 (7.4)	-7.40 (4.57)	-31.7 (24.5)

33. Secondary Outcome

Title	Change in Fasting Glucose Levels
Description	Glucose will be measured in a fasting serum sample at Quest Lab.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	33	24	36	13
Mean (Standard Error); Unit of Measure: mg/dL
	0.33 (1.74)	0.04 (2.02)	-2.78 (1.44)	-8.54 (4.31)

34. Secondary Outcome

Title	Change in Insulin
Description	Insulin will be measured using an immunoassay at Quest lab.
Time Frame	12 weeks from baseline

Outcome Measure Data

Analysis Population Description

All randomized and treated participants with data available at the given time-point.

Arm/Group Title	Placebo	LY2452473 Dose 1	LY2452473 Dose 2	LY2452473 Dose 3
Arm/Group Description:	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.	The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.	The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Overall Number of Participants Analyzed	15	11	16	3
Mean (Standard Error); Unit of Measure: uIU/mL
	-0.17 (0.93)	0.36 (1.52)	-1.63 (0.68)	-1.00 (0.50)

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo		LY2452473 Dose 1		LY2452473 Dose 2		LY2452473 Dose 3
Arm/Group Description	Placebo: The participants will receive pills containing no active drug daily for 12-weeks.		The participants will receive 1 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.		The participants will receive 5 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.		The participants will receive 15 mg LY2452473 daily for 12-weeks. LY2452473: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
All-Cause Mortality
	Placebo		LY2452473 Dose 1		LY2452473 Dose 2		LY2452473 Dose 3
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Serious Adverse Events
	Placebo		LY2452473 Dose 1		LY2452473 Dose 2		LY2452473 Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/36 (5.56%)		2/28 (7.14%)		1/36 (2.78%)		1/14 (7.14%)
Cardiac disorders
Myocardial infarction † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Musculoskeletal and connective tissue disorders
Pain in extremity † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Pain in extremity † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic ocular melanoma † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Renal and urinary disorders
Renal Cancer † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Surgical and medical procedures
Coronary artery bypass † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
1 Term from vocabulary, MedDRA (24.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo		LY2452473 Dose 1		LY2452473 Dose 2		LY2452473 Dose 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/36 (91.67%)		22/28 (78.57%)		33/36 (91.67%)		10/14 (71.43%)
Blood and lymphatic system disorders
Lymphadenopathy † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Cardiac disorders
Angina pectoris † 1	0/36 (0.00%)		2/28 (7.14%)	4	0/36 (0.00%)		0/14 (0.00%)
Atrial fibrillation † 1	1/36 (2.78%)	2	0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Chest discomfort † 1	0/36 (0.00%)		1/28 (3.57%)	2	0/36 (0.00%)		0/14 (0.00%)
Dizziness † 1	1/36 (2.78%)	3	0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Palpitations † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Tachycardia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Ventricular arrhythmia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Ventricular tachycardia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Endocrine disorders
Diabetes mellitus † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Goitre † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Eye disorders
Asthenopia † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Cataract † 1	2/36 (5.56%)	3	1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Diplopia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Dry eye † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Eye haemorrhage † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Iritis † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Lacrimation increased † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Ocular hyperaemia † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Vision blurred † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Gastrointestinal disorders
Abdominal discomfort † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Abdominal distension † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Abdominal pain † 1	1/36 (2.78%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Constipation † 1	1/36 (2.78%)		1/28 (3.57%)		2/36 (5.56%)		0/14 (0.00%)
Diarrhoea † 1	3/36 (8.33%)		1/28 (3.57%)		0/36 (0.00%)		1/14 (7.14%)
Diverticulitis † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Dyspepsia † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Dysphagia † 1	1/36 (2.78%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Faeces discoloured † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Flatulence † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Gastroesophageal reflux disease † 1	1/36 (2.78%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Glossodynia † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Hiatus hernia † 1	0/36 (0.00%)		0/28 (0.00%)		2/36 (5.56%)		0/14 (0.00%)
Inguinal hernia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Nausea † 1	4/36 (11.11%)	5	1/28 (3.57%)		1/36 (2.78%)		0/14 (0.00%)
Oesophageal food impaction † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Oral pain † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		1/14 (7.14%)
Swollen tongue † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Toothache † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Vomiting † 1	2/36 (5.56%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
General disorders
Decreased appetite † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Fatigue † 1	5/36 (13.89%)		1/28 (3.57%)		2/36 (5.56%)		1/14 (7.14%)
Increased appetite † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Influenza like illness † 1	1/36 (2.78%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Night sweats † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Non-cardiac chest pain † 1	1/36 (2.78%)		1/28 (3.57%)		1/36 (2.78%)		0/14 (0.00%)
Pain † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Pyrexia † 1	1/36 (2.78%)		2/28 (7.14%)		0/36 (0.00%)		0/14 (0.00%)
Immune system disorders
Hypersensitivity † 1	1/36 (2.78%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Infections and infestations
Bronchitis † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Lyme Disease † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Nasopharyngitis † 1	1/36 (2.78%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Norovirus infection † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Pharyngitis streptococcal † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Pneumonia † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Sinusitis † 1	2/36 (5.56%)		0/28 (0.00%)		2/36 (5.56%)	3	1/14 (7.14%)
Skin infection † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Tooth infection † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Upper respiratory tract infection † 1	3/36 (8.33%)		0/28 (0.00%)		2/36 (5.56%)		0/14 (0.00%)
Injury, poisoning and procedural complications
Animal bite † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Arthropod bite † 1	2/36 (5.56%)		2/28 (7.14%)		2/36 (5.56%)		0/14 (0.00%)
Contusion † 1	2/36 (5.56%)	3	0/28 (0.00%)		1/36 (2.78%)		3/14 (21.43%)	11
Face injury † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Fall † 1	0/36 (0.00%)		1/28 (3.57%)	3	0/36 (0.00%)		0/14 (0.00%)
Hand injury † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Ligament sprain † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Palate injury † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Post procedural complication † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Skin abrasion † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		1/14 (7.14%)	2
Sunburn † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Thermal burn † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)	3	0/14 (0.00%)
Wound † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Investigations
Alanine aminotransferase increased † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Biopsy skin † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Blood cholesterol increased † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Blood iron decreased † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Breath sounds abnormal † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Electrocardiogram ST segment depression † 1	0/36 (0.00%)		1/28 (3.57%)		1/36 (2.78%)		0/14 (0.00%)
Metabolism and nutrition disorders
Hyperglycaemia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Hypertriglyceridemia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Musculoskeletal and connective tissue disorders
Ankle impingement † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Arthralgia † 1	1/36 (2.78%)		2/28 (7.14%)		3/36 (8.33%)		0/14 (0.00%)
Arthritis † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Back pain † 1	2/36 (5.56%)		5/28 (17.86%)		2/36 (5.56%)	3	2/14 (14.29%)
Joint effusion † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Ligament sprain † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Muscle spasms † 1	1/36 (2.78%)	2	1/28 (3.57%)		1/36 (2.78%)		1/14 (7.14%)
Muscle strain † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Muscular weakness † 1	0/36 (0.00%)		2/28 (7.14%)		2/36 (5.56%)		0/14 (0.00%)
Myalgia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		1/14 (7.14%)	2
Neck pain † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Pain in extremity † 1	2/36 (5.56%)	3	0/28 (0.00%)		5/36 (13.89%)	8	2/14 (14.29%)
Plantar fasciitis † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Sciatica † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Tendonitis † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer fatigue † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Cyst † 1	1/36 (2.78%)	3	0/28 (0.00%)		1/36 (2.78%)	2	0/14 (0.00%)
Renal cyst † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Thyroid cyst † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Nervous system disorders
Cognitive disorder † 1	2/36 (5.56%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Headache † 1	2/36 (5.56%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Migraine † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Paraesthesia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Presyncope † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Syncope † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Taste disorder † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Psychiatric disorders
Anxiety † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Depression † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		1/14 (7.14%)
Renal and urinary disorders
Chromaturia † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Haematuria † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Micturition disorder † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Polyuria † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Urinary incontinence † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Reproductive system and breast disorders
Scrotal pain † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Testicular pain † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	3/36 (8.33%)		4/28 (14.29%)		4/36 (11.11%)		1/14 (7.14%)
Dyspnoea † 1	1/36 (2.78%)		2/28 (7.14%)		1/36 (2.78%)		1/14 (7.14%)
Nasal congestion † 1	3/36 (8.33%)		5/28 (17.86%)		0/36 (0.00%)		2/14 (14.29%)
Obstructive airways disorder † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Oropharyngeal pain † 1	0/36 (0.00%)		2/28 (7.14%)		5/36 (13.89%)		0/14 (0.00%)
Rhinitis allergic † 1	0/36 (0.00%)		0/28 (0.00%)		0/36 (0.00%)		2/14 (14.29%)
Sinus pain † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Skin and subcutaneous tissue disorders
Abdominal pain † 1	0/36 (0.00%)		1/28 (3.57%)		0/36 (0.00%)		0/14 (0.00%)
Actinic keratosis † 1	0/36 (0.00%)		1/28 (3.57%)	2	1/36 (2.78%)		0/14 (0.00%)
Alopecia † 1	0/36 (0.00%)		0/28 (0.00%)		2/36 (5.56%)		0/14 (0.00%)
Basal cell carcinoma † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)	2	0/14 (0.00%)
Dermatitis contact † 1	0/36 (0.00%)		1/28 (3.57%)		1/36 (2.78%)		0/14 (0.00%)
Dry skin † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)
Pain of skin † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Pruritus † 1	0/36 (0.00%)		1/28 (3.57%)		2/36 (5.56%)		0/14 (0.00%)
Psoriasis † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Rash † 1	2/36 (5.56%)		0/28 (0.00%)		0/36 (0.00%)		1/14 (7.14%)	2
Rash maculo-papular † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Rosacea † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Skin abrasion † 1	0/36 (0.00%)		2/28 (7.14%)		0/36 (0.00%)		0/14 (0.00%)
Skin induration † 1	1/36 (2.78%)		0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Skin laceration † 1	2/36 (5.56%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Skin mass † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Urticaria † 1	0/36 (0.00%)		0/28 (0.00%)		1/36 (2.78%)		0/14 (0.00%)
Surgical and medical procedures
Cataract operation † 1	1/36 (2.78%)	2	0/28 (0.00%)		0/36 (0.00%)		0/14 (0.00%)
Vascular disorders
Haematoma † 1	0/36 (0.00%)		2/28 (7.14%)		1/36 (2.78%)		0/14 (0.00%)
Hypertension † 1	0/36 (0.00%)		1/28 (3.57%)		3/36 (8.33%)		1/14 (7.14%)
1 Term from vocabulary, MedDRA (24.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Shalender Bhasin, Principal Investigator
• Organization: Brigham and Women's hospital
• Phone: 617 525 9150
• EMail: sbhasin@bwh.harvard.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pencina KM, Burnett AL, Storer TW, Guo W, Li Z, Kibel AS, Huang G, Blouin M, Berry DL, Basaria S, Bhasin S. A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors: A Randomized Trial. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2171-2186. doi: 10.1210/clinem/dgab361.

• Responsible Party: Shalender Bhasin, MD, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT02499497
• Other Study ID Numbers: 15-120
• First Submitted: July 6, 2015
• First Posted: July 16, 2015
• Results First Submitted: August 23, 2021
• Results First Posted: September 28, 2021
• Last Update Posted: September 28, 2021