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

Erectile Dysfunction Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ejaculation
• Erectile Dysfunction
• Sexual Dysfunction

• NCT number: NCT01230762
• Study type: Interventional
• Source: Alza Corporation, DE, USA
• Status: Completed
• Phase: Phase 3
• Completion date: April 2005