Status:
COMPLETED
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation.
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Ejaculation
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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).
Detailed Description
One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). An objective measurement of PE in clinical studies is the intravaginal ejaculato...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
1294 Patients enrolled
Trial Details
Trial ID
NCT00211107
Start Date
June 1 2003
End Date
June 1 2004
Last Update
May 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.