A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00229073
First received: September 27, 2005
Last updated: June 6, 2011
Last verified: March 2010
  Purpose

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).


Condition Intervention Phase
Erectile Dysfunction
Drug: dapoxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study Of The Efficacy And Safety Of Dapoxetine In The Treatment Of Subjects With Premature Ejaculation

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)

Secondary Outcome Measures:
  • Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at monthly intervals through Week 24; incidence, severity, and type of adverse events throughout study and follow up (Week 27)

Enrollment: 1116
Study Start Date: December 2004
Study Completion Date: October 2006
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 3 phases: pre-randomization phase (a screening visit and a 4-week baseline period); 24-week double-blind treatment phase during which patients will receive dapoxetine or placebo for use on an "as-needed" basis; and, 1-week double-blind withdrawal phase (dapoxetine or placebo) with a post-study telephone contact approximately 2 weeks after the end of treatment. The total duration of the study is approximately 31 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 throughout treatment and follow up (Week 27), as well as laboratory tests and questionnaires to monitor possible changes in mood, anxiety, motor responses, and sexual function at specified times during the study. The study hypothesis is that treatment for 24 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 24 weeks of treatment. No more than 1 dose within a 24-hour period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • good general health
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229073

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00229073     History of Changes
Other Study ID Numbers: CR004231
Study First Received: September 27, 2005
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
dapoxetine
premature ejaculation
ejaculation
sexual dysfunction
orgasmic disorder
sexual intercourse

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

ClinicalTrials.gov processed this record on August 01, 2014