Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

Phase 3

• Conditions: Premature Ejaculation
• Interventions: Drug: Promescent Lidocaine Spray; Drug: Placebo

• Registration Number: NCT02241460
• Lead Sponsor: Eugene Y Rhee, MD

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 Description

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-12
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-12
• Last Update Submitted: 2014-09-12
• Study First Posted: 2014-09-16
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Promescent Lidocaine Spray	Promescent Lidocaine Spray	Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out
Placebo	Placebo	Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out
Placebo	Promescent Lidocaine Spray	Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Adverse events/reactions to treatments	Week 11
Subjective distress	Week 3, 7, and 11
Perceived optimal dosage of treatment	Week 3, 7, and 11
Perception of improvement in premature ejaculation	Week 3, 7, and 11

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 San Diego, California, United States