Erectile Dysfunction Clinical Trial
Official title:
An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Verified date | January 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 purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.
Status | Completed |
Enrollment | 1774 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alza Corporation, DE, USA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events reported | Up to 9 months | No | |
Primary | Results from physical examinations | Months 3 and 9 or termination visit | No | |
Primary | Results from vital signs measurements | Months 1, 2 and 6 | No | |
Primary | Results from clinical laboratory tests | Months 1, 3, and 9 or termination visit | No | |
Primary | Results from ECGs | At the 3 month visit and the 9 month visit/Termination Visit | No | |
Secondary | Results from patient reported outcomes (PRO) for perception of sexual functioning | During use of dapoxetine for up to 9 months | No |
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