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

Phase 3

Completed

• Conditions: Ejaculation; Erectile Dysfunction; Sexual Dysfunction
• Interventions: Drug: dapoxetine

• Registration Number: NCT01230762
• Lead Sponsor: Alza Corporation, DE, USA

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 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 Timeline

• Study Completion: 2005-04
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Status Verified: 2011-01
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1774

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
001	dapoxetine	dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months

Primary Outcome Measures

Name	Time	Method
Adverse events reported	Up to 9 months
Results from physical examinations	Months 3 and 9 or termination visit
Results from vital signs measurements	Months 1, 2 and 6
Results from clinical laboratory tests	Months 1, 3, and 9 or termination visit
Results from ECGs	At the 3 month visit and the 9 month visit/Termination Visit

Secondary Outcome Measures

Name	Time	Method
Results from patient reported outcomes (PRO) for perception of sexual functioning	During use of dapoxetine for up to 9 months