PSD502 in Subjects With Premature Ejaculation

Completed · Phase 2 · Has a placebo group

Conditions studied: Premature Ejaculation

In brief

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.

Key facts

Study ID

NCT03578783

Run by

Plethora Solutions Ltd

People needed

121

Starts

2018-12-26

Expected to finish

2021-12-01

Last updated by the study team

2022-07-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.
• Subject has received PSD502 in a clinical study or has received Fortacin within 1 year of Screening.

Where it is running

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

Full record on ClinicalTrials.gov

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