Phase 3
Completed N=256
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
Premature Ejaculation
Source: ClinicalTrials.gov NCT00556478 ↗
Enrolled (actual)
256
Serious AEs
1.3%
Results posted
Sep 2016
Primary outcomePrimary: Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment — 4.607; 1.505 ratio — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.