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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230762
• Other study ID #: CR005041
• Secondary ID: C-2002-014
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: May 18, 2011
• Est. completion date: April 2005

Study information

• Verified date: January 2011
• Source: Alza Corporation, DE, USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1774
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ejaculation
• Erectile Dysfunction
• Sexual Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alza Corporation, DE, USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events reported		Up to 9 months	No
Primary	Results from physical examinations		Months 3 and 9 or termination visit	No
Primary	Results from vital signs measurements		Months 1, 2 and 6	No
Primary	Results from clinical laboratory tests		Months 1, 3, and 9 or termination visit	No
Primary	Results from ECGs		At the 3 month visit and the 9 month visit/Termination Visit	No
Secondary	Results from patient reported outcomes (PRO) for perception of sexual functioning		During use of dapoxetine for up to 9 months	No

External Links

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