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A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.
Details
| Lead sponsor | Eugene Y Rhee, MD |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2014-03 |
| Completion | 2015-12 |
Conditions
- Premature Ejaculation
Interventions
- Placebo
- Promescent Lidocaine Spray
Primary outcomes
- Intravaginal Ejaculatory Latency Time (IELT) in seconds — Week 11
The primary efficacy outcome is the proportion of subjects that achieve a mean IELT of greater than 90 seconds at Week 3, 7, and 11.
Countries
United States