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

NCT ID: NCT01230762

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1774 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-04-30

Brief Summary

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

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.

Conditions

Ejaculation; Erectile Dysfunction; Sexual Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

dapoxetine

Intervention Type: DRUG

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

Interventions

dapoxetine

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

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alza Corporation, DE, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Principal Investigators

Alza Corporation Clinical Trial

Role: STUDY_DIRECTOR

ALZA

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=95&filename=CR005041_CSR.pdf

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

Other Identifiers

C-2002-014

Identifier Type: -

Identifier Source: secondary_id

CR005041

Identifier Type: -

Identifier Source: org_study_id