Working… Menu

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature 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: NCT00211107
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 19, 2011
Information provided by:
Alza Corporation, DE, USA

Brief Summary:
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 or disease Intervention/treatment Phase
Ejaculation Drug: Dapoxetine Phase 3

Detailed Description:
One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a randomized, double-blind study in men with PE. The study consists of 2 phases: pre-randomization phase (a screening visit and a 2-week baseline period); 12-week double-blind treatment phase during which patients will receive dapoxetine at one of two dosages, or placebo, for use on an "as-needed" basis. The total duration of the study is approximately 14 weeks. Patients and their partners are expected to attempt sexual intercourse at least 4 times during the baseline period and at least 6 times each month during the treatment phase. Assessments of effectiveness include the average Intravaginal Ejaculatory Latency time (IELT), as measured by stopwatch, during sexual intercourse for the treatment period (12 weeks); 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 (12 weeks), vital sign measurements (pulse and blood pressure) and laboratory tests (hematology, chemistry, urinalysis) at monthly intervals. 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) taken as needed during 12 weeks of treatment. No more than one dose within a 24-hour period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blind, Randomized, Parallel Study Of The Efficacy And Safety Of Dapoxetine HCl In The Treatment Of Rapid Ejaculation
Study Start Date : June 2003
Actual Study Completion Date : June 2004

Primary Outcome Measures :
  1. Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period

Secondary Outcome Measures :
  1. Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study and through Week 12; incidence, severity, and type of adverse events throughout study (12 weeks).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Heterosexual male in a stable, monogamous, sexual relationship with a female partner for at least 6 months
  • onset of orgasm and ejaculation occurs with minimal sexual stimulation before or shortly after penetration and before the person wishes it
  • premature ejaculation (PE) in the majority of intercourse experiences in the 6 months before study initiation
  • intravaginal latency ejaculatory time (IELT) of <=2 minutes in at least 3 out of 4 events
  • participants with partners of child-bearing potential must consent to use a medically acceptable method of contraception throughout the entire study
  • participant's partner must have a negative pregnancy test at time of screening.

Exclusion Criteria:

  • History of surgery or injury to the pelvis or spinal cord, chronic inflammation of the prostate or urethra
  • taking medications that are contraindicated for participation in the study
  • currently using other forms of therapy for treatment of PE (for example, behavioral therapy or medications applied locally)
  • previously participated in a drug study involving dapoxetine or in another drug trial within the last month
  • taken pimozide, astemizole, or monoamine oxidase inhibitors within 6 months of the start of the study.

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): NCT00211107

Sponsors and Collaborators
Alza Corporation, DE, USA
Layout table for investigator information
Study Director: Alza Corporation Clinical Trial ALZA

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00211107     History of Changes
Other Study ID Numbers: CR006088
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: March 2010
Keywords provided by Alza Corporation, DE, USA:
rapid ejaculation
premature ejaculation
sexual dysfunction
orgasmic disorder
sexual intercourse
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Ejaculation
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders