A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
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ClinicalTrials.gov Identifier: NCT00211094 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : February 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ejaculation | Drug: Dapoxetine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Placebo-Controlled, Double-blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation |
Actual Study Completion Date : | June 2004 |
- 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
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211094
Study Director: | Alza Corporation Clinical Trial | ALZA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00211094 |
Other Study ID Numbers: |
CR006091 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | February 11, 2011 |
Last Verified: | February 2011 |
dapoxetine premature ejaculation ejaculation |
sexual dysfunction orgasmic disorder sexual intercourse |
Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |