PSD502 in Subjects With Premature Ejaculation

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578783
• Other study ID #: PSD502-PE-008
• Status: Completed
• Phase: Phase 2
• Start date: December 26, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Plethora Solutions Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 1, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

1. Urological disease (e.g., prostatitis, urinary tract infection) or genitourinary surgery within 8 weeks of Screening.

2. 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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Primary Care Research	Atlanta	Georgia
United States	Midlantic Urology	Bala-Cynwyd	Pennsylvania
United States	Achieve Clinical Research	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Imagine Research of Palm Beach County	Boynton Beach	Florida
United States	Mens Health Boston	Chestnut Hill	Massachusetts
United States	Accumed Research Associates	Garden City	New York
United States	Jubilee Clinical Research, Inc	Las Vegas	Nevada
United States	Georgia Clinical Research, Llc	Lawrenceville	Georgia
United States	SunCoast Research	Miami	Florida
United States	Suncoast Research Associates	Miami Lakes	Florida
United States	Coastal Clinical Research	Mobile	Alabama
United States	Manhattan Medical Research Practice	New York	New York
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Advanced Clinical Research - Jordan Ridge Family Medicine	Salt Lake City	Utah
United States	Skyline Urology	Sherman Oaks	California
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Advanced Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Plethora Solutions Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between Baseline and 4 weeks : Success on the Premature Ejaculation Bothersome Evaluation Questionnaire PEBEQ Item 3 (event-specific bother)	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	Baseline and 4 week treatment period
Secondary	Patient Global Impression of Change	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?'	4 weeks post treatment
Secondary	Patient Global Impression of Severity	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'.	Baseline and 4 week treatment period
Secondary	Patient Global Impression of Change-Bother	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?'.	4 weeks post treatment
Secondary	Intravaginal ejaculatory latency time	Change from baseline in intravaginal ejaculatory latency time	Baseline and 4 week treatment period
Secondary	Independent Ejaculation Quickness Item	Change from baseline in patient-reported impression of how quickly they ejaculated during each attempt of sexual intercourse	Baseline and 4 week treatment period
Secondary	Index of Premature Ejaculation Control Domain Score	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.	4 weeks post treatment
Secondary	Index of Premature Ejaculation Distress Domain Score	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.	4 weeks post treatment
Secondary	Index of Premature Ejaculation Satisfaction Domain Score	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.	4 weeks post treatment
Secondary	Independent Numeric Response Scale Bother Item	Change from baseline in patient-reported assessment of bother during each attempt of sexual intercourse	Baseline and 4 week treatment period
Secondary	Psychometric properties of the Premature Ejaculation Bothersome Evaluation Questionnaire Item 3 (event-specific bother)	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'	4 weeks post treatment