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

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

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Erectile Dysfunction; Ejaculation
• Intervention / Treatment: Drug: dapoxetine

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 Type: Interventional
• Enrollment (Actual): 1774
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Alza Corporation, DE, USA

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (Estimate): October 29, 2010

Study Record Updates

• Last Update Posted (Estimate): May 19, 2011
• Last Update Submitted That Met QC Criteria: May 18, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Premature ejaculation; Ejaculation; Sexual dysfunction; Sexual intercourse; Dapoxetine, Orgasmic disorder
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: CR005041; C-2002-014