PSD502 in Subjects With Premature Ejaculation

Sponsor

Plethora Solutions Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03578783

Collaborator

(none)

121

Enrollment

Locations

Arms

35.2

Actual Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ejaculation	Drug: Placebo Drug: PSD502	Phase 2

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

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 26, 2018

Actual Primary Completion Date :

May 4, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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

Outcome Measures

Primary Outcome Measures

Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother) [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

Patient Global Impression of Change [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', 'Moderately better', 'A little better', 'About the same', 'A little worse', 'Moderately worse' and 'A great deal worse'. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'
Patient Global Impression of Severity [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', 'Mildly Severe', 'Moderately Severe', 'Very Severe' and 'Extremely Severe'.
Patient Global Impression of Change-Bother [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', 'Bothered moderately less', 'Bothered a little less', 'Bothered about the same', 'Bothered a little worse', 'Bothered moderately worse' and 'Bothered a great deal worse'. Subjects will also be asked to provide a 'Yes' or 'No' response to the question 'Was this a meaningful or important change for you?'.
Intravaginal ejaculatory latency time [Baseline and 4 week treatment period]
Change from baseline in intravaginal ejaculatory latency time
Independent Ejaculation Quickness Item [Baseline and 4 week treatment period]
Change from baseline in patient-reported impression of how quickly they ejaculated during each attempt of sexual intercourse
Index of Premature Ejaculation Control Domain Score [4 weeks post treatment]
Change from baseline in the Index of Premature Ejaculation Control Domain Score. The domain is based on 4 items (score range 4-20). Low scores represent a worse value.
Index of Premature Ejaculation Distress Domain Score [4 weeks post treatment]
Change from baseline in the Index of Premature Ejaculation Distress Domain Score. The domain is based on two items (score range 2-10). Low scores represent a worse value.
Index of Premature Ejaculation Satisfaction Domain Score [4 weeks post treatment]
Change from baseline in the Index of Premature Ejaculation Satisfaction Domain Score. The domain is based on 4 items (score range 4-20). Low scores represent a worse value.
Independent Numeric Response Scale Bother Item [Baseline and 4 week treatment period]
Change from baseline in patient-reported assessment of bother during each attempt of sexual intercourse
Psychometric properties of the Premature Ejaculation Bothersome Evaluation Questionnaire Item 3 (event-specific bother) [4 weeks post treatment]
Patient-reported impression of how bothered they were by how quickly they ejaculated during each attempt of sexual intercourse. Subjects will be asked to provide a response to the question 'How bothered were you by how quickly you ejaculated during the sexual intercourse you just engaged in?' on a 5-point scale of 'Not at All', 'A Little Bit', 'Moderately', 'Quite a Bit' and 'Extremely'

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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 and Locations

Locations

	Site	City	State	Country	Postal Code
1	Achieve Clinical Research	Birmingham	Alabama	United States	35216
2	Coastal Clinical Research	Mobile	Alabama	United States	36608
3	Skyline Urology	Sherman Oaks	California	United States	91411
4	Imagine Research of Palm Beach County	Boynton Beach	Florida	United States	33435
5	Suncoast Research Associates	Miami Lakes	Florida	United States	33014
6	SunCoast Research	Miami	Florida	United States	33133
7	Clinical Research Center of Florida	Pompano Beach	Florida	United States	33060
8	Primary Care Research	Atlanta	Georgia	United States	30312
9	Georgia Clinical Research, Llc	Lawrenceville	Georgia	United States	30044
10	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
11	Chesapeake Urology Research Associates	Towson	Maryland	United States	21204
12	Boston Clinical Trials	Boston	Massachusetts	United States	02131
13	Mens Health Boston	Chestnut Hill	Massachusetts	United States	02467
14	Jubilee Clinical Research, Inc	Las Vegas	Nevada	United States	89106
15	Accumed Research Associates	Garden City	New York	United States	11530
16	Manhattan Medical Research Practice	New York	New York	United States	10016
17	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
18	M3 Wake Research, Inc	Raleigh	North Carolina	United States	27612
19	Midlantic Urology	Bala-Cynwyd	Pennsylvania	United States	19004
20	Advanced Clinical Research - Jordan Ridge Family Medicine	Salt Lake City	Utah	United States	84123
21	Advanced Clinical Research	West Jordan	Utah	United States	84088

Sponsors and Collaborators

Plethora Solutions Ltd

Investigators

Principal Investigator: Jed Kaminetsky, MD, BA, Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Plethora Solutions Ltd

ClinicalTrials.gov Identifier:

NCT03578783

Other Study ID Numbers:

PSD502-PE-008

First Posted:

Jul 6, 2018

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Premature Ejaculation

Lidocaine, Prilocaine Drug Combination

Study Results

No Results Posted as of Jul 5, 2022