History of Changes for Study: NCT03578783

General Comments

Quality Control Review Comment provided by the National Library of Medicine:

This record has new issues that must be addressed.

Study Identification


Unique Protocol ID:	PSD502-PE-008
Brief Title:	PSD502 in Subjects With Premature Ejaculation
Official Title:	A Pilot Multicenter, Randomized, Double-Blind Study Comparing The Proportion Of Responders to PSD502 and to Placebo Using the PEBEQ In Subjects With Premature Ejaculation
Secondary IDs:

Study Status


Record Verification:	September 2022
Overall Status:	Completed
Study Start:	December 26, 2018
Primary Completion:	May 4, 2021 [Actual]
Study Completion:	December 1, 2021 [Actual]

First Submitted:	June 14, 2018
First Submitted that Met QC Criteria:	July 5, 2018
First Posted:	July 6, 2018 [Actual]

Results First Submitted:	August 4, 2022
Results First Submitted that Met QC Criteria:
Results First Posted:	October 21, 2022 [Actual]

Last Update Submitted that Met QC Criteria:
Last Update Posted:	October 21, 2022 [Actual]

Study Description

Brief Summary:

This study is being done to test the effect of PSD502 (the study medication) compared to placebo in subjects with premature ejaculation. PSD502 is a topical (applied to skin) anesthetic spray containing a mixture of two drugs called lidocaine and prilocaine that will be applied to the penis. Half of the subjects will receive PSD502 and half will receive placebo.

Detailed Description:

The study will assess whether the bothersome symptoms of premature ejaculation (PE) are helped when treated with PSD502 by answering questionnaires such as the 'Premature Ejaculation Bothersome Evaluation Questionnaire' (PEBEQ) and 'Index of Premature Ejaculation© (IPE) and some additional questions about premature ejaculation.

The study will also measure the effect of PSD502 on the Intravaginal Ejaculatory Latency Time (IELT). This is the time between when the penis enters the vagina and when the subject starts to ejaculate in the vagina.

Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 1:1 ratio.

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	121 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: PSD502 PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis.	Drug: PSD502 For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing. Other Names: mixture of lidocaine and prilocaine
Placebo Comparator: Placebo The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone).	Drug: Placebo For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing. Other Names: PEG600 and Povidone

Outcome Measures

[See Results Section.]


Primary Outcome Measures:
1.	Change Between Baseline and 4 Weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (Event-specific Bother) [ Time Frame: Baseline and 4 week treatment period ] Success is defined as having a 1-point or greater improvement between the mean response over the treatment period and the mean response during the baseline period
Secondary Outcome Measures:
1.	Patient Global Impression of Change (PGI-C) - Meaningful Change [ Time Frame: 4 weeks post treatment ] Patient-reported global impression of change in the quickness of their ejaculation. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'
2.	Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline and 4 week treatment period ] Change from baseline in patient-reported impression of severity of the quickness of their ejaculation. Subjects will be asked to answer the question 'Overall, how severe is the quickness of your ejaculation?' Using a 5-point scale of 'Not Severe' (0), 'Mildly Severe' (1), 'Moderately Severe' (2), 'Very Severe' (3) and 'Extremely Severe' (4).
3.	Patient Global Impression of Change-Bother (PGI-C Bother) [ Time Frame: 4 weeks post treatment ] Patient-reported global impression of change in the bother resulting from the quickness of their ejaculation. Subjects will be asked to provide a response to the following question 'Compared to when you started the study, how would you describe any change in how much you are bothered by the quickness of your ejaculation now?' on a 7-point scale of: 'Bothered a great deal less' (3), 'Bothered moderately less' (2), 'Bothered a little less' (1), 'Bothered about the same' (0), 'Bothered a little worse' (-1), Bothered moderately worse' (-2) and 'Bothered a great deal worse' (-3). Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'.
4.	Intravaginal Ejaculatory Latency Time (IELT) [ Time Frame: Baseline and 4 week treatment period ] Change from baseline in intravaginal ejaculatory latency time (IELT); The IELT is a standard assessment used to evaluate premature ejaculation. In this study, IELT eligibility is based on the first evidence-based ISSM definition of PE2, i.e., IELT ≤1 minute (for all baseline sexual encounters). The unit of measure is seconds.
5.	Independent Ejaculation Quickness Item (IEQI) [ Time Frame: Baseline and 4 week treatment period ] Change from baseline in patient-reported impression of how quickly they ejaculated during each attempt of sexual intercourse. This item asked the subject to answer the question 'How quickly do you feel you ejaculated during the sexual intercourse you just engaged in?' using a 5-point scale of 'Not quick at all' (0), 'Slightly quick' (1), 'Moderately quick' (2), 'Very quick' (3) and 'Extremely quick' (4). The IEQI was completed by the subject for all sexual encounters during the study.
6.	Index of Premature Ejaculation (IPE) Control Domain Score [ Time Frame: 4 weeks post treatment ] This item asked the subject to answer questions about the effects his sexual problems have had on his sex life over the past four weeks. This 10-item questionnaire is divided into three domains that assess sexual satisfaction (4 questions; score range 4-20 ), ejaculatory control (4 questions, score range 4-20), and distress (2 questions, score range 2-10). For all questions, the minimum value is 1 and the maximum value is 5, with 5 being a better outcome and 1 being a worse outcome. If No sexual intercourse (not applicable)', is selected the answers will be treated as 'missing' in the calculation of domain scores. If 50% or more of the questions within a particular domain are answered with a non-missing response, the domain score will be calculated as follows: Score = total number of questions in domain x (sum of non-missing/number of non-missing) If less than 50% of domain questions are answered, the domain score will be missing.
7.	Independent Numeric Response Scale Bother Item (Independent NRS Bother) [ Time Frame: Baseline and 4 week treatment period ] This scale asks the subject, "How bothered were you this time by how quickly you ejaculated?" This scale goes from 0, "Not Bothered at All" to 10, "As bothered as I can imagine". The subject was asked to circle the number that best reflected his answer. The subject was asked to complete this item at the Screening Visit, as well as after each sexual encounter during the study.
8.	Patient Global Impression of Change (PGI-C) Score [ Time Frame: 4 weeks post treatment ] Patient-reported global impression of change in the quickness of their ejaculation. Subjects will be asked to provide a response to the question 'Compared to when you started the study, how would you describe any change in how quickly you ejaculate now?' on a 7-point scale of: 'A great deal better' (3), 'Moderately better' (2), 'A little better' (1), 'About the same' (0), 'A little worse' (-1), 'Moderately worse' (-2) and 'A great deal worse' (-3).

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	Male
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Willing and able to provide written informed consent. Male and aged 18 years and over. Diagnosed with PE according to the ISSM definition, that is, he ejaculates always or nearly always prior to or within about one minute of vaginal penetration; and is unable to delay ejaculation on all or nearly all vaginal penetrations; and experiences negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy. Subject has lifelong PE from the first sexual experience. Subject must be in a stable heterosexual and monogamous relationship of at least 3 months' duration with this partner. Subject has at least documented 3 sexual encounters, each separated by an interval of at least 24 hours, in the baseline period. IELT ≤1 minute in all sexual encounters in the baseline period. The subject's partner must provide written informed consent, be aged 18 years or over and willing to comply with the study procedures. Subject indicates a level of Bother on Item 3 of the PEBEQ of either "moderately", "quite a bit" or "extremely" on all encounters during the baseline period. Subject registers a level of "bother" at a score of 4 or greater on an 11-point NRS scale at Screening to ensure that subjects not bothered by the quickness of their ejaculation are not entered into the baseline period. Exclusion Criteria: Subject, or his sexual partner, has received an investigational (unapproved) drug within 30 days of Screening. Subject has erectile dysfunction, defined as an IIEF-5 score of 21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator. The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following: Urological disease (e.g., prostatitis, urinary tract infection) or genitourinary surgery within 8 weeks of Screening. Ongoing significant psychiatric disorder (e.g., bipolar disease, depression / anxiety disorder or schizophrenia) not controlled by medication. Subject has safety testing abnormalities at the Screening Visit, in particular liver function tests or anemia, that are indicative of a medical condition that would preclude further participation in the opinion of the Investigator. Subjects taking tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs), for indications other than PE, where the dose has been changed within 4 weeks of Screening or it is planned that the dose will change during the treatment period. Subject has received any treatment for PE e.g., anti-depressant therapy, local anesthetic spray, eutectic mixture of local anesthetics (EMLA®) cream, intra-cavernosal injection, tramadol or psychotherapy within 4 weeks of Screening Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator. The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons. Subject, or his sexual partner, has known drug sensitivity to amide-type local anesthetics. Subjects with pregnant partners. Subject with sexual partners of child-bearing potential and not using appropriate contraception (hormonal contraception or intra-uterine device [IUD]). Subject, or his sexual partner, has a history of glucose-6-phosphate dehydrogenase (G 6 PD) deficiency or currently using medications that would increase susceptibility to methemoglobinemia (e.g., anti-malarial agents) or has congenital or acquired methemoglobinemia, or is at risk of industrial exposure to agents causing methemoglobinemia. Subject, or his sexual partner, uses Class I (e.g., mexiletine, tocainide) or III (e.g., amiodarone, sotalol) anti-arrhythmic drugs, or cimetidine, beta blockers or local anesthetics. Subject has received PSD502 in a clinical study or has received Fortacin within 1 year of Screening.

Contacts/Locations


Study Officials:	Jed Kaminetsky, MD, BA Principal Investigator Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016
Locations:	United States, Alabama
	Achieve Clinical Research Birmingham, Alabama, United States, 35216
	Coastal Clinical Research Mobile, Alabama, United States, 36608
	United States, California
	Skyline Urology Sherman Oaks, California, United States, 91411
	United States, Florida
	Imagine Research of Palm Beach County Boynton Beach, Florida, United States, 33435
	SunCoast Research Miami, Florida, United States, 33133
	Suncoast Research Associates Miami Lakes, Florida, United States, 33014
	Clinical Research Center of Florida Pompano Beach, Florida, United States, 33060
	United States, Georgia
	Primary Care Research Atlanta, Georgia, United States, 30312
	Georgia Clinical Research, Llc Lawrenceville, Georgia, United States, 30044
	United States, Louisiana
	Regional Urology, LLC Shreveport, Louisiana, United States, 71106
	United States, Maryland
	Chesapeake Urology Research Associates Towson, Maryland, United States, 21204
	United States, Massachusetts
	Boston Clinical Trials Boston, Massachusetts, United States, 02131
	Mens Health Boston Chestnut Hill, Massachusetts, United States, 02467
	United States, Nevada
	Jubilee Clinical Research, Inc Las Vegas, Nevada, United States, 89106
	United States, New York
	Accumed Research Associates Garden City, New York, United States, 11530
	Manhattan Medical Research Practice New York, New York, United States, 10016
	Premier Medical Group of the Hudson Valley Poughkeepsie, New York, United States, 12601
	United States, North Carolina
	M3 Wake Research, Inc Raleigh, North Carolina, United States, 27612
	United States, Pennsylvania
	Midlantic Urology Bala-Cynwyd, Pennsylvania, United States, 19004
	United States, Utah
	Advanced Clinical Research - Jordan Ridge Family Medicine Salt Lake City, Utah, United States, 84123
	Advanced Clinical Research West Jordan, Utah, United States, 84088

Document Section


	Study Protocol Document Date: June 24, 2019 Uploaded: 09/19/2022 12:56 File Name: Prot_002.pdf
	Statistical Analysis Plan Document Date: April 29, 2021 Uploaded: 09/19/2022 12:56 File Name: SAP_003.pdf

Study Results

Participant Flow

Recruitment Details

Pre-assignment Details

Ninety-two subjects were randomized in the study. Of these 92 subjects, 91 received PSD502. One subject was randomized in error and did not receive study drug. Ninety-one (91) subjects received PSD502.

Arm/Group Title

PSD502

Placebo

Arm/Group Description

PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis.

PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.

Study subjects should leave at least 24 hours between each dosing.

The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone).

Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.

Study subjects should leave at least 24 hours between each dosing.

Quality Control Review Comment provided by the National Library of Medicine:

Information within the Participant Flow module appears inconsistent.

Period Title: Overall Study

Started

41^[1]

Completed

39^[2]

Not Completed

[1]	First subject was randomize
[2]	Last Subject Last Visit

Baseline Characteristics

Arm/Group Title

PSD502

Placebo

Total

Arm/Group Description

PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.

Study subjects should leave at least 24 hours between each dosing.

Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.

Study subjects should leave at least 24 hours between each dosing.

Total of all reporting groups

Overall Number of Baseline Participants

Baseline Analysis Population Description

[Not Specified]

Age, Categorical

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

41 Participants

50 Participants

91 Participants

<=18 years

Between 18 and 65 years

100%

>=65 years

Sex/Gender, Customized^[1]

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

41 Participants

50 Participants

91 Participants

Number of Participants

[1]	Measure Description: Male and aged 18 years and over

Quality Control Review Comment provided by the National Library of Medicine:

One or more of the baseline measures appear to be used inappropriately. Required data may be missing.

Ethnicity (NIH/OMB)

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

41 Participants

50 Participants

91 Participants

Hispanic or Latino

26.83%

20%

23.08%

Not Hispanic or Latino

60.98%

68%

64.84%

Unknown or Not Reported

12.2%

12%

12.09%

Race (NIH/OMB)^[1]

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

41 Participants

50 Participants

91 Participants

American Indian or Alaska Native

Asian

2.44%

1.1%

Native Hawaiian or Other Pacific Islander

Black or African American

31.71%

34%

32.97%

White

31.71%

34%

32.97%

More than one race

Unknown or Not Reported

34.15%

32%

32.97%

[1]	Measure Description: Only people received one dose of active under the Intent To Treat. Under other the additional patients included under Other 3 did not return. Other patients did not use active at all, some partners declined participation which excluded the subject.

Region of Enrollment

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

41 Participants

50 Participants

91 Participants

United States

Intravaginal Ejaculatory Latency Time (IELT)^[1]

Measure Type: Number
Unit of measure: participants

Number Analyzed

41 Participants

50 Participants

91 Participants

[1]

Measure Description: IELT: intravaginal ejaculatory latency time; To be eligible to continue in the study, the subject had to have recorded a baseline IELT of ≤1 minute for all sexual encounters in the baseline period. The results reflect those eligible to participate in the study based on meeting the above parameters.

Outcome Measures

1. Primary Outcome:

Title

Change Between Baseline and 4 Weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (Event-specific Bother)

Description

Success is defined as having a 1-point or greater improvement between the mean response over the treatment period and the mean response during the baseline period

Time Frame

Baseline and 4 week treatment period

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: included all eligible randomized subjects who received at least one dose of a study drug and who had at least three observations of PEBEQ Item 3 (event-specific bother) in the baseline period and at least one in the treatment period. Subjects were analyzed according to the treatment they were assigned to at randomization, irrespective of what treatment they actually received


Arm/Group Title		PSD502	Placebo
Arm/Group Description		PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed		38	45
Measure Type: Count of Participants Unit of Measure: Participants	Successful (Yes)	26 68.4%	15 33.3%
	Not Successful (No)	12 31.6%	30 66.7%

2. Secondary Outcome:

Title

Patient Global Impression of Change (PGI-C) - Meaningful Change

Description

Patient-reported global impression of change in the quickness of their ejaculation. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'

Time Frame

4 weeks post treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title		PSD502	Placebo
Arm/Group Description		PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed		38	45
Measure Type: Count of Participants Unit of Measure: Participants	Was this a meaningful or important change for you? (Yes)	27 71.1%	22 48.9%
	Was this a meaningful or important change for you? (No)	11 28.9%	23 51.1%

3. Secondary Outcome:

Title

Patient Global Impression of Severity (PGI-S)

Description

Change from baseline in patient-reported impression of severity of the quickness of their ejaculation. Subjects will be asked to answer the question 'Overall, how severe is the quickness of your ejaculation?' Using a 5-point scale of 'Not Severe' (0), 'Mildly Severe' (1), 'Moderately Severe' (2), 'Very Severe' (3) and 'Extremely Severe' (4).

Time Frame

Baseline and 4 week treatment period

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: Included all eligible randomized subjects who received at least one dose of a study drug and who had at least three observations of PEBEQ Item 3 (event-specific bother) in the baseline period and at least one in the treatment period. Subjects were analyzed according to the treatment they were assigned to at randomization, irrespective of what treatment they actually received.


Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed	38	45
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline	3.27(0.511)	3.37(0.576)
Treatment	1.69(1.306)	2.58(1.344)

4. Secondary Outcome:

Title

Patient Global Impression of Change-Bother (PGI-C Bother)

Description

Patient-reported global impression of change in the bother resulting from the quickness of their ejaculation. Subjects will be asked to provide a response to the following question 'Compared to when you started the study, how would you describe any change in how much you are bothered by the quickness of your ejaculation now?' on a 7-point scale of: 'Bothered a great deal less' (3), 'Bothered moderately less' (2), 'Bothered a little less' (1), 'Bothered about the same' (0), 'Bothered a little worse' (-1), Bothered moderately worse' (-2) and 'Bothered a great deal worse' (-3). Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'.

Time Frame

4 weeks post treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title		PSD502	Placebo
Arm/Group Description		PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed		38	45
Measure Type: Count of Participants Unit of Measure: Participants	Was this a meaningful or important change for you? (Yes)	27 71.1%	21 46.7%
	Was this a meaningful or important change for you? (No)	10 26.3%	24 53.3%
	Missing	1 2.6%	0 0%

5. Secondary Outcome:

Title

Intravaginal Ejaculatory Latency Time (IELT)

Description

Change from baseline in intravaginal ejaculatory latency time (IELT); The IELT is a standard assessment used to evaluate premature ejaculation. In this study, IELT eligibility is based on the first evidence-based ISSM definition of PE2, i.e., IELT ≤1 minute (for all baseline sexual encounters). The unit of measure is seconds.

Time Frame

Baseline and 4 week treatment period

Outcome Measure Data

Analysis Population Description


Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed	38	45
Mean (Standard Deviation) Unit of Measure: Seconds
Baseline	41.69(8.445)	35.06(10.868)
Treatment	350.1(425.031)	213.84(330.835)

6. Secondary Outcome:

Title

Independent Ejaculation Quickness Item (IEQI)

Description

Change from baseline in patient-reported impression of how quickly they ejaculated during each attempt of sexual intercourse. This item asked the subject to answer the question 'How quickly do you feel you ejaculated during the sexual intercourse you just engaged in?' using a 5-point scale of 'Not quick at all' (0), 'Slightly quick' (1), 'Moderately quick' (2), 'Very quick' (3) and 'Extremely quick' (4). The IEQI was completed by the subject for all sexual encounters during the study.

Time Frame

Baseline and 4 week treatment period

Outcome Measure Data

Analysis Population Description


Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed	38	45
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	3.34(0.530)	3.41(0.494)
Treatment	1.61(1.256)	2.58(1.313)

7. Secondary Outcome:

Title

Index of Premature Ejaculation (IPE) Control Domain Score

Description

This item asked the subject to answer questions about the effects his sexual problems have had on his sex life over the past four weeks. This 10-item questionnaire is divided into three domains that assess sexual satisfaction (4 questions; score range 4-20 ), ejaculatory control (4 questions, score range 4-20), and distress (2 questions, score range 2-10). For all questions, the minimum value is 1 and the maximum value is 5, with 5 being a better outcome and 1 being a worse outcome. If No sexual intercourse (not applicable)', is selected the answers will be treated as 'missing' in the calculation of domain scores. If 50% or more of the questions within a particular domain are answered with a non-missing response, the domain score will be calculated as follows:

Score = total number of questions in domain x (sum of non-missing/number of non-missing) If less than 50% of domain questions are answered, the domain score will be missing.

Time Frame

4 weeks post treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed	38	45
Mean (Standard Deviation) Unit of Measure: score on a scale
Sexual Satisfaction (Change from Baseline)	7.0(6.30)	4.6(6.21)
Ejaculation Control (Change from Baseline)	7.8(6.12)	4.8(5.88)
Distress (Change from Baseline)	3.5(2.87)	1.8(3.30)

8. Secondary Outcome:

Title

Independent Numeric Response Scale Bother Item (Independent NRS Bother)

Description

This scale asks the subject, "How bothered were you this time by how quickly you ejaculated?" This scale goes from 0, "Not Bothered at All" to 10, "As bothered as I can imagine". The subject was asked to circle the number that best reflected his answer. The subject was asked to complete this item at the Screening Visit, as well as after each sexual encounter during the study.

Time Frame

Baseline and 4 week treatment period

Outcome Measure Data

Analysis Population Description


Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed	38	45
Mean (Standard Deviation) Unit of Measure: score on a scale
Baseline	8.71(1.310)	8.78(1.317)
Treatment	4.69(3.490)	6.64(3.339)

9. Secondary Outcome:

Title

Patient Global Impression of Change (PGI-C) Score

Description

Patient-reported global impression of change in the quickness of their ejaculation. Subjects will be asked to provide a response to the question 'Compared to when you started the study, how would you describe any change in how quickly you ejaculate now?' on a 7-point scale of: 'A great deal better' (3), 'Moderately better' (2), 'A little better' (1), 'About the same' (0), 'A little worse' (-1), 'Moderately worse' (-2) and 'A great deal worse' (-3).

Time Frame

4 weeks post treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing.
Overall Number of Participants Analyzed	38	45
Mean (Standard Deviation) Unit of Measure: score on a scale	1.2(1.62)	0.9(1.34)

Adverse Events


Time Frame	Treatment-Emergent Adverse events collected from Randomization (4 weeks) to end of Study (8 weeks).
Adverse Event Reporting Description	Safety Population - All subjects who received the study drug

Arm/Group Title	PSD502	Placebo
Arm/Group Description	PSD502 spray contains a eutectic-like mixture of lidocaine and prilocaine, and a propellant (norflurane) which also serves as a solvent. Each spray contains 7.5 mg lidocaine and 2.5 mg prilocaine. A single dose consists of 3 sprays applied to the glans penis. PSD502: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing. 4 subjects that received PSD502 reported Adverse Events	The placebo is a metered dose spray, identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine (instead it contains PEG600 and Povidone). Placebo: For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration. Study subjects should leave at least 24 hours between each dosing. 3 subjects that received placebo reported Adverse Events
All-Cause Mortality
	PSD502	Placebo
	Affected / At Risk (%)	Affected / At Risk (%)
Total	0 / 39 (0%)	0 / 46 (0%)
Serious Adverse Events
	PSD502	Placebo
	Affected / At Risk (%)	Affected / At Risk (%)
Total	0 / 39 (0%)	0 / 46 (0%)

Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	PSD502	Placebo
	Affected / At Risk (%)	Affected / At Risk (%)
Total	0 / 39 (0%)	0 / 46 (0%)

More Information


Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. PI may not submit results of this study for publication/presentation without prior written Sponsor approval. Sponsor will review intended publications in advance, and subject to agreed revisions, allow publication within 45 days. Sponsor agrees to provide Investigators at least 30 days for review of its manuscripts prior to submission. Sponsor will not publicly identify or otherwise refer to the Investigator(s) in connection with the study without prior consent.
Results Point of Contact:
Name/Official Title:	Nancy Clementi MD
Organization:	Clementi & Associates
Phone:	610-527-2700
Email:	nclementi@regulatoryaffairs.com