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

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT01230762
First received: October 28, 2010
Last updated: May 18, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Ejaculation
Erectile Dysfunction
Sexual Dysfunction
 Drug: dapoxetine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • Adverse events reported [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
  • Results from physical examinations [ Time Frame: Months 3 and 9 or termination visit ] [ Designated as safety issue: No ]
  • Results from vital signs measurements [ Time Frame: Months 1, 2 and 6 ] [ Designated as safety issue: No ]
  • Results from clinical laboratory tests [ Time Frame: Months 1, 3, and 9 or termination visit ] [ Designated as safety issue: No ]
  • Results from ECGs [ Time Frame: At the 3 month visit and the 9 month visit/Termination Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Results from patient reported outcomes (PRO) for perception of sexual functioning [ Time Frame: During use of dapoxetine for up to 9 months ] [ Designated as safety issue: No ]

Enrollment: 1774
Study Completion Date: April 2005
Arms Assigned Interventions
Experimental: 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
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230762

Sponsors and Collaborators
Alza Corporation, DE, USA
Investigators
Study Director: Alza Corporation Clinical Trial ALZA
  More Information

Additional Information:
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: SR DIRECTOR CLINICAL LEADER, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01230762     History of Changes
Other Study ID Numbers: CR005041, C-2002-014
Study First Received: October 28, 2010
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:
Dapoxetine, Orgasmic disorder
Premature ejaculation
Sexual dysfunction
 Sexual intercourse
Ejaculation
Erectile Dysfunction

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Erectile Dysfunction
Sexual and Gender Disorders
 Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 19, 2013