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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01230762
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : May 19, 2011
Information provided by:
Alza Corporation, DE, USA

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

Condition or disease Intervention/treatment Phase
Ejaculation Erectile Dysfunction Sexual Dysfunction Drug: dapoxetine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1774 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Completion Date : April 2005

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Adverse events reported [ Time Frame: Up to 9 months ]
  2. Results from physical examinations [ Time Frame: Months 3 and 9 or termination visit ]
  3. Results from vital signs measurements [ Time Frame: Months 1, 2 and 6 ]
  4. Results from clinical laboratory tests [ Time Frame: Months 1, 3, and 9 or termination visit ]
  5. Results from ECGs [ Time Frame: At the 3 month visit and the 9 month visit/Termination Visit ]

Secondary Outcome Measures :
  1. Results from patient reported outcomes (PRO) for perception of sexual functioning [ Time Frame: During use of dapoxetine for up to 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230762

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

Additional Information:
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Responsible Party: SR DIRECTOR CLINICAL LEADER, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Identifier: NCT01230762     History of Changes
Other Study ID Numbers: CR005041
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: January 2011
Keywords provided by Alza Corporation, DE, USA:
Dapoxetine, Orgasmic disorder
Premature ejaculation
Sexual dysfunction
Sexual intercourse
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders