An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Primary Purpose
Ejaculation, Erectile Dysfunction, Sexual Dysfunction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dapoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Ejaculation focused on measuring Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
001
Arm Description
dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months
Outcomes
Primary Outcome Measures
Adverse events reported
Results from physical examinations
Results from vital signs measurements
Results from clinical laboratory tests
Results from ECGs
Secondary Outcome Measures
Results from patient reported outcomes (PRO) for perception of sexual functioning
Full Information
NCT ID
NCT01230762
First Posted
October 28, 2010
Last Updated
May 18, 2011
Sponsor
Alza Corporation, DE, USA
1. Study Identification
Unique Protocol Identification Number
NCT01230762
Brief Title
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Official Title
An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alza Corporation, DE, USA
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ejaculation, Erectile Dysfunction, Sexual Dysfunction
Keywords
Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1774 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
dapoxetine
Intervention Description
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 Measure Information:
Title
Adverse events reported
Time Frame
Up to 9 months
Title
Results from physical examinations
Time Frame
Months 3 and 9 or termination visit
Title
Results from vital signs measurements
Time Frame
Months 1, 2 and 6
Title
Results from clinical laboratory tests
Time Frame
Months 1, 3, and 9 or termination visit
Title
Results from ECGs
Time Frame
At the 3 month visit and the 9 month visit/Termination Visit
Secondary Outcome Measure Information:
Title
Results from patient reported outcomes (PRO) for perception of sexual functioning
Time Frame
During use of dapoxetine for up to 9 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alza Corporation Clinical Trial
Organizational Affiliation
ALZA
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=95&filename=CR005041_CSR.pdf
Description
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation.
Learn more about this trial
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
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