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

Alza Corporation

Status and phase

Completed

Phase 3

Conditions

Erectile Dysfunction

Sexual Dysfunction

Ejaculation

Treatments

Drug: dapoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230762

C-2002-014

CR005041

Details and patient eligibility

About

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

Full 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.

Enrollment

1,774 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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