Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eugene Y Rhee, MD
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Subject has provided written informed consent before screening.

• Subject is a male, 18 years of age or older.

• Subject meets the diagnostic criteria for premature ejaculation as defined by the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; 2000).

• Subject has a stable, monogamous, heterosexual relationship and sexually active for at least the last 6 months.

• Subject and partner are willing and able to engage in sexual intercourse.

Exclusion Criteria:

• Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e., always ejaculates prior to penetration).

• Subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation, anejaculation, painful ejaculation).

• In the opinion of the investigator, the subject has a condition or is in a situation that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to participate in the study.