Phase 3
N=256
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
Premature Ejaculation
Bottom Line
View on ClinicalTrials.gov: NCT00556478 ↗Enrolled (actual)
256
Serious AEs
1.3%
Results posted
Sep 2016
Primary outcome: Primary: Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment — 4.607; 1.505 ratio — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PSD502, contains a mixture of lidocaine and prilocaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Plethora Solutions Ltd
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment |
4.607; 1.505 | <0.0001 sig |
| PRIMARY Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3 |
7.2; 2.2; 6.6; 2.1; 3.5; 0.9 | <0.0001 sig |
| SECONDARY Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment |
80.2; 37.8; 57.5; 14.6 | — |
| SECONDARY Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3 |
140.964; 49.615 | — |
| SECONDARY Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1 |
5.7; 1.3; 2.5; 0.6; 5.1; 1.8 | — |
| SECONDARY Subject PEP at Month 1 |
59.6; 23.5; 63.4; 27.2; 62.7; 33.3 | — |
| SECONDARY Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2 |
6.5; 1.4; 5.8; 1.3; 2.9; 0.7 | — |
| SECONDARY Subject Premature Ejaculation Profile (PEP) at Month 2 |
67.5; 24.7; 70.1; 33.8; 69.4; 27.3 | — |
| SECONDARY Subject Premature Ejaculation Profile (PEP) at Month 3 |
72.4; 24.1; 76.9; 36.7; 73.7; 36.7 | — |
| SECONDARY Partner Premature Ejaculation Profile (PEP) at Month 3 |
68.9; 40.8; 64.9; 50.0; 62.8; 32.9 | — |
Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent.
- Male and aged 18 years and over.
- Diagnosed with PE according to DMS-IV criteria and ISSM definition
- Diagnosed with lifelong PE
- Acceptable response to Baseline PEP
- Subject must be in a stable heterosexual and monogamous relationship and the partner must provide consent
- Acceptable sexual encounters in the Baseline period.
Exclusion Criteria
- Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening.
- Subject has erectile dysfunction
- 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
- Ongoing significant psychiatric disorder not controlled by medication.
- Subject has safety testing abnormalities at the Screening Visit
- Subjects taking excluded medications or receiving any treatment for PE
- Subject, or his sexual partner, has a current history of alcohol or drug abuse,
- 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
- Subject, or his sexual partner, has a history of Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents).
Data sourced from ClinicalTrials.gov (NCT00556478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.