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 | February 2011 |
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 | 1320 |
Est. completion date | June 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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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 at the end of the treatment period (Week 12) for both doses of dapoxetine | |||
Secondary | Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 12; incidence, severity, and type of adverse events throughout study; medication helpfulness |
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