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

Sponsor

Alza Corporation, DE, USA (Industry)

Overall Status

Completed

CT.gov ID

NCT01230762

Collaborator

(none)

1,774

Enrollment

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ejaculation Erectile Dysfunction Sexual Dysfunction	Drug: dapoxetine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1774 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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