PSD502 in Subjects With Premature Ejaculation

NCT03578783 | Completed Phase 2 FDA Drug

• 1 other identifier: PSD502-PE-008
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 21

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.

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Patient Global Impression of Change

  4 weeks post treatment

• Patient Global Impression of Severity

  Baseline and 4 week treatment period

• Patient Global Impression of Change-Bother

  4 weeks post treatment

• Intravaginal ejaculatory latency time

  Baseline and 4 week treatment period

• Independent Ejaculation Quickness Item

  Baseline and 4 week treatment period

Study Arms (2)

PSD502

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

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

PSD502 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Plethora Solutions Ltd: lead

Study Sites (21)

Achieve Clinical Research

Birmingham, Alabama, 35216, United States

Location

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Skyline Urology

Sherman Oaks, California, 91411, United States

Location

Imagine Research of Palm Beach County

Boynton Beach, Florida, 33435, United States

Location

SunCoast Research

Miami, Florida, 33133, United States

Location

Suncoast Research Associates

Miami Lakes, Florida, 33014, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Primary Care Research

Atlanta, Georgia, 30312, United States

Location

Georgia Clinical Research, Llc

Lawrenceville, Georgia, 30044, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Mens Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

Jubilee Clinical Research, Inc

Las Vegas, Nevada, 89106, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice

New York, New York, 10016, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

Location

Midlantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Advanced Clinical Research - Jordan Ridge Family Medicine

Salt Lake City, Utah, 84123, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jed Kaminetsky, MD, BA

  Manhattan Medical Research, 215 Lexington Avenue, 21st Floor, New York, NY 10016

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 6, 2018
• Study Start: December 26, 2018
• Primary Completion: May 4, 2021
• Study Completion: December 1, 2021
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)