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). The study consists of 2 phases: pre-randomization phase (a screening visit and a...
Eligibility Criteria
Inclusion
- Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
- history of premature ejaculation in the 6 months before study initiation not due to distress, interpersonal difficulty or medication withdrawal
- history of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least 3 out of 4 events
- blood pressure \< = 180/100 mmHg at screening and end of baseline
- patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
- patient's partner must have a negative urine pregnancy test at time of screening
Exclusion
- Not taken dapoxetine in a previous investigational drug study
- not using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
- no history of any medical events that are associated with the development of PE
- not taken another investigational drug within 1 month
- no history of seizures or major psychiatric disorder such as depression or schizophrenia
- no alcohol abuse and dependence
- no known allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors (SSRIs)
- no partners with decreased interest in or painful intercourse or other forms of sexual dysfunction
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
1320 Patients enrolled
Trial Details
Trial ID
NCT00211094
End Date
June 1 2004
Last Update
February 11 2011
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