- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210704
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).
Study Overview
Detailed Description
Premature ejaculation (PE) is a form of male sexual dysfunction.
An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT).
This is a multicenter, placebo-controlled, double-blind, randomized, parallel-group study in men with PE.
The study will consist 2 phases: pre-randomization phase (a screening visit and a 4-week baseline period); 12-week double-blind treatment phase during which patients will receive dapoxetine or placebo for use on an "as-needed" basis, with a post-study telephone contact approximately 2 weeks after the end of treatment.
The total duration of the study is approximately 18 weeks.
Assessments of effectiveness include the average intravaginal ejaculatory latency time (as measured by stopwatch) during sexual intercourse, during the treatment period; control over ejaculation, satisfaction with sexual intercourse, and severity of symptoms, based on questions asked at monthly intervals through the treatment phase.
Safety assessments include the incidence, severity, and type of adverse events during the study, as well as laboratory tests and questionnaires to monitor sexual function at specified times during the study.
The study hypothesis is that treatment for 12 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE.
Oral tablets of dapoxetine (30 milligrams[mg] or 60mg) or placebo taken as needed during 12 weeks of treatment.
No more than 1 dose within a 24-hour period.
Study Type
Interventional
Enrollment (Actual)
1067
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male citizens of Asian countries and Australia are encouraged to enroll in the study
- patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
- diagnosis of premature ejaculation (PE) according to the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for at least 6 months before study initiation
- history of intravaginal ejaculatory latency time (IELT) of <2 minutes in at least 3 out of 4 events
- patient's partner must have a negative urine pregnancy test at time of screening
- Exclusion Criteria:
- Not taken dapoxetine or participated in another study investigating pharmacologic treatment of PE within the last 3 months
- no history of any medical events that are associated with the development of PE
- not taken another investigational drug within 1 month, or used an experimental medical device within 6 months of study initiation
- no positive diagnosis of depressive or anxiety disorder, manic episode, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, schizophrenia, or other psychotic disorders
- no known allergy or hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12)
|
Secondary Outcome Measures
Outcome Measure |
---|
Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 12; incidence, severity, and type of adverse events throughout study and follow up (Week 14).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.
- Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. J Sex Med. 2010 Jun;7(6):2231-2242. doi: 10.1111/j.1743-6109.2010.01820.x. Epub 2010 Apr 19.
- McMahon C, Kim SW, Park NC, Chang CP, Rivas D, Tesfaye F, Rothman M, Aquilina J; Dapoxetine 3003 Study Investigators. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med. 2010 Jan;7(1 Pt 1):256-68. doi: 10.1111/j.1743-6109.2009.01560.x. Epub 2009 Oct 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004228
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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