NCT01230762

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,774 (actual)
• Sponsor: Alza Corporation, DE, USA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.

Conditions

• Ejaculation
• Erectile Dysfunction
• Sexual Dysfunction

Interventions

Type	Name	Description
DRUG	dapoxetine	60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months

Timeline

• Completion: 2005-04-01
• First posted: 2010-10-29
• Last updated: 2011-05-19