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

Alza Corporation, DE, USA1,774 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,774

Conditions

Ejaculation Erectile Dysfunction Sexual Dysfunction

Interventions

dapoxetineDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse events reported

Time frame: Up to 9 months

Results from physical examinations

Time frame: Months 3 and 9 or termination visit

Results from vital signs measurements

Time frame: Months 1, 2 and 6

Results from clinical laboratory tests

Time frame: Months 1, 3, and 9 or termination visit

Results from ECGs

Time frame: At the 3 month visit and the 9 month visit/Termination Visit

Secondary Outcomes

Results from patient reported outcomes (PRO) for perception of sexual functioning

Time frame: During use of dapoxetine for up to 9 months

Data from ClinicalTrials.gov

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