Ejaculation Clinical Trial
Official title:
A Placebo-Controlled, Double-Blind, Randomized, Parallel Study Of The Efficacy And Safety Of Dapoxetine HCl In The Treatment Of Rapid Ejaculation
Verified date | March 2010 |
Source | Alza Corporation, DE, USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).
Status | Completed |
Enrollment | 1294 |
Est. completion date | June 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Heterosexual male in a stable, monogamous, sexual relationship with a female partner for at least 6 months - onset of orgasm and ejaculation occurs with minimal sexual stimulation before or shortly after penetration and before the person wishes it - premature ejaculation (PE) in the majority of intercourse experiences in the 6 months before study initiation - intravaginal latency ejaculatory time (IELT) of <=2 minutes in at least 3 out of 4 events - participants with partners of child-bearing potential must consent to use a medically acceptable method of contraception throughout the entire study - participant's partner must have a negative pregnancy test at time of screening. Exclusion Criteria: - History of surgery or injury to the pelvis or spinal cord, chronic inflammation of the prostate or urethra - taking medications that are contraindicated for participation in the study - currently using other forms of therapy for treatment of PE (for example, behavioral therapy or medications applied locally) - previously participated in a drug study involving dapoxetine or in another drug trial within the last month - taken pimozide, astemizole, or monoamine oxidase inhibitors within 6 months of the start of the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alza Corporation, DE, USA |
Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S; Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised contro — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period | |||
Secondary | Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study and through Week 12; incidence, severity, and type of adverse events throughout study (12 weeks). |
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