Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

• ClinicalTrials.gov Identifier: NCT01057901
• Recruitment Status: Terminated
• First Posted: January 28, 2010
• Results First Posted: June 17, 2014
• Last Update Posted: June 17, 2014
• Sponsor: Sprout Pharmaceuticals, Inc
• Information provided by (Responsible Party): Sprout Pharmaceuticals, Inc

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Sexual Dysfunctions, Psychological
• Interventions: Drug: Flibanserin; Drug: Placebo
• Enrollment: 748

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Flibanserin 100 mg	Placebo
Arm/Group Description	Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Period Title: Overall Study
Started	376	372
Completed	116	126
Not Completed	260	246

Baseline Characteristics

Arm/Group Title		Flibanserin 100 mg	Placebo	Total
Arm/Group Description		Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.	Total of all reporting groups
Overall Number of Baseline Participants		376	372	748
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	376 participants	372 participants	748 participants
less than 45 years		4	5	9
45-54 years		154	128	282
55-64		196	212	408
65 years and older		22	27	49
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	376 participants	372 participants	748 participants
	Female	376 100.0%	372 100.0%	748 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	376 participants	372 participants	748 participants
White		324	310	634
White Hispanic		18	27	45
Black/African American		25	26	51
Black/African American Hispanic		1	1	2
Asian		8	4	12
Asian Hispanic		0	0	0
American Indian/Alaskan Native		0	2	2
Hawaiian/Pacific Islander		0	2	2

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Number of Satisfying Sexual Events
Description	The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Time Frame	baseline to 24 weeks

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.

Arm/Group Title	Flibanserin 100 mg	Placebo
Arm/Group Description:	Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Overall Number of Participants Analyzed	346	335
Mean (Standard Deviation); Unit of Measure: SSEs/month
	1.0 (3.3)	0.7 (2.9)

2. Primary Outcome

Title	Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
Description	The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
Time Frame	baseline to 24 weeks

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.

Arm/Group Title	Flibanserin 100 mg	Placebo
Arm/Group Description:	Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks	This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
Overall Number of Participants Analyzed	351	343
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.6 (0.1)	0.4 (0.1)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Among the 372 randomized patients, 369 took at least one dose of study medication and had at least one post-dose on-treatment safety assessment. These patients were included in the treated set that was analyzed for safety.
Arm/Group Title	Flibanserin 100 mg		Placebo
Arm/Group Description	Flibanserin 100 mg administered at bedtime Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks		This is the matched placebo which will be administered two tablets daily at bedtime. Placebo: This is the matched placebo which will be administered two tablets daily at bedtime.
All-Cause Mortality
	Flibanserin 100 mg		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Flibanserin 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/376 (1.60%)		4/369 (1.08%)
Infections and infestations
Diverticulitis †	0/376 (0.00%)	0	1/369 (0.27%)	1
Gastroenteritis viral †	1/376 (0.27%)	1	0/369 (0.00%)	0
Injury, poisoning and procedural complications
Fall †	0/376 (0.00%)	0	1/369 (0.27%)	1
hip fracture †	0/376 (0.00%)	0	1/369 (0.27%)	1
meniscus lesion †	1/376 (0.27%)	1	0/369 (0.00%)	0
road traffic accident †	1/376 (0.27%)	1	0/369 (0.00%)	0
tibia fracture †	1/376 (0.27%)	1	0/369 (0.00%)	0
Investigations
Liver function test abnormal †	1/376 (0.27%)	1	0/369 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in situ †	1/376 (0.27%)	1	0/369 (0.00%)	0
Nervous system disorders
Transient ischemic event †	0/376 (0.00%)	0	1/369 (0.27%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Flibanserin 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	118/376 (31.38%)		74/369 (20.05%)
Gastrointestinal disorders
nausea †	20/376 (5.32%)	21	15/369 (4.07%)	15
Nervous system disorders
somnolence †	26/376 (6.91%)	27	8/369 (2.17%)	9
headache †	19/376 (5.05%)	21	24/369 (6.50%)	27
dizziness †	24/376 (6.38%)	28	13/369 (3.52%)	14
Psychiatric disorders
Insomnia †	29/376 (7.71%)	30	14/369 (3.79%)	14
† 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: Krista Barbour, Ph.D.
• Organization: Sprout Pharmaceuticals
• Phone: 9198820850
• EMail: kbarbour@sproutpharma.com

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

Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med. 2017 Jun;14(6):834-842. doi: 10.1016/j.jsxm.2017.03.258.

• Responsible Party: Sprout Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01057901
• Other Study ID Numbers: 511.156
• First Submitted: January 25, 2010
• First Posted: January 28, 2010
• Results First Submitted: April 14, 2014
• Results First Posted: June 17, 2014
• Last Update Posted: June 17, 2014