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

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

Detailed Description
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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.

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

Conditions
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Ejaculation, Erectile Dysfunction, Sexual Dysfunction

Intervention / Treatment
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* Drug: dapoxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>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<br>* 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation