NCT00211094

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
1,320

participants targeted

Target at P75+ 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 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

February 11, 2011

Status Verified

February 1, 2011

First QC Date

September 15, 2005

Last Update Submit

February 10, 2011

Conditions

Ejaculation

Keywords

dapoxetinepremature ejaculationejaculationsexual dysfunctionorgasmic disordersexual intercourse

Outcome Measures

Primary Outcomes (1)

  • Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12) for both doses of dapoxetine

Secondary Outcomes (1)

  • 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; medication helpfulness

Interventions

DapoxetineDRUG

Eligibility Criteria

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

You may qualify if:

  • 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
  • history of premature ejaculation in the 6 months before study initiation not due to distress, interpersonal difficulty or medication withdrawal
  • history of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least 3 out of 4 events
  • blood pressure \< = 180/100 mmHg at screening and end of baseline
  • patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
  • patient's partner must have a negative urine pregnancy test at time of screening

You may not qualify if:

  • Not taken dapoxetine in a previous investigational drug study
  • not using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
  • no history of any medical events that are associated with the development of PE
  • not taken another investigational drug within 1 month
  • no history of seizures or major psychiatric disorder such as depression or schizophrenia
  • no alcohol abuse and dependence
  • no known allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors (SSRIs)
  • no partners with decreased interest in or painful intercourse or other forms of sexual dysfunction

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

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 Completion

June 1, 2004

Last Updated

February 11, 2011

Record last verified: 2011-02