Status:
UNKNOWN
Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
Lead Sponsor:
Eugene Y Rhee, MD
Conditions:
Premature Ejaculation
Eligibility:
MALE
18+ years
Phase:
PHASE3
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. I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02241460
Start Date
March 1 2014
End Date
December 1 2015
Last Update
September 16 2014
Active Locations (2)
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1
Kaiser Permanente
Los Angeles, California, United States, 90027
2
Kaiser Permanente
San Diego, California, United States, 92154