NCT00211107

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,294

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

May 19, 2011

Status Verified

March 1, 2010

First QC Date

September 15, 2005

Last Update Submit

May 18, 2011

Conditions

Ejaculation

Keywords

dapoxetinerapid ejaculationpremature ejaculationejaculationsexual dysfunctionorgasmic disordersexual intercourse

Outcome Measures

Primary Outcomes (1)

  • Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period

Secondary Outcomes (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).

Interventions

DapoxetineDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S; Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006 Sep 9;368(9539):929-37. doi: 10.1016/S0140-6736(06)69373-2.

    PMID: 16962882RESULT

  • 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.

    PMID: 21059176DERIVED

Related Links

MeSH Terms

Conditions

Premature EjaculationSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalCoitus

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesMental DisordersSexual BehaviorBehavior

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 21, 2005

Study Start

June 1, 2003

Study Completion

June 1, 2004

Last Updated

May 19, 2011

Record last verified: 2010-03