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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.
ClinicalTrials.gov Identifier: NCT00211094
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
Alza Corporation, DE, USA

Tracking Information
First Submitted Date  ICMJE September 15, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date February 11, 2011
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00211094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
Official Title  ICMJE A Placebo-Controlled, Double-blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
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).
Detailed Description One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). 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 one of 2 doses of dapoxetine or placebo for use on an "as-needed" basis. The total duration of the study is approximately 14 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, participant and partner satisfaction with sexual intercourse, participant overall impression of change 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, ECGs, as well as laboratory tests. At the end of the baseline period, patients from selected study centers will undergo blood sampling and ECG monitoring before and after the first dose of study medication. 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ejaculation
Intervention  ICMJE Drug: Dapoxetine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2011)
1320
Original Enrollment  ICMJE
 (submitted: September 15, 2005)
1200
Actual Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00211094
Other Study ID Numbers  ICMJE CR006091
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Alza Corporation, DE, USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alza Corporation Clinical Trial ALZA
PRS Account Alza Corporation, DE, USA
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP