An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA

Criteria

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