Clinical Trial: Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

Brief Summary: The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.

Detailed Summary: Promescent Lidocaine Spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital desensitizing drug products. In addition the evaluating the efficacy of treatment with Promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of Promescent for patients with premature ejaculation and their respective partners.
Sponsor: Eugene Y Rhee, MD

Current Primary Outcome: Intravaginal Ejaculatory Latency Time (IELT) in seconds [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjective distress [ Time Frame: Week 3, 7, and 11 ]
  • Perception of improvement in premature ejaculation [ Time Frame: Week 3, 7, and 11 ]
  • Perceived optimal dosage of treatment [ Time Frame: Week 3, 7, and 11 ]
  • Adverse events/reactions to treatments [ Time Frame: Week 11 ]


Original Secondary Outcome: Same as current

Information By: Kaiser Permanente

Dates:
Date Received: May 12, 2014
Date Started: March 2014
Date Completion: December 2015
Last Updated: September 12, 2014
Last Verified: September 2014