Status:
COMPLETED
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Ejaculation
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.
Detailed Description
This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult...
Eligibility Criteria
Inclusion
- Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013)
- In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment
- Had a systolic blood pressure of \<=180 mm Hg and a diastolic blood pressure \<=100 mm Hg
- Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study
Exclusion
- Currently taking any any protocol-defined prohibited medications
- Reported a diagnosis of any sexually transmitted disease, Had a new allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors
- In the opinion of the Investigator is incapable of following the study schedule for any reason
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
1774 Patients enrolled
Trial Details
Trial ID
NCT01230762
End Date
April 1 2005
Last Update
May 19 2011
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