A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
Overview
- Phase
- Phase 3
- Intervention
- Promescent Lidocaine Spray
- Conditions
- Premature Ejaculation
- Sponsor
- Eugene Y Rhee, MD
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Intravaginal Ejaculatory Latency Time (IELT) in seconds
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eugene Y Rhee, MD
Chief, Department of Urologic Surgery
Kaiser Permanente
Eligibility 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.
Arms & Interventions
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
Intervention: Promescent Lidocaine Spray
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
Intervention: 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
Intervention: Promescent Lidocaine Spray
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)