A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation. - Full Text View

Sponsor:	Alza Corporation, DE, USA
Information provided by:	Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:	NCT00211107

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
Ejaculation	Drug: Dapoxetine	Phase III

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 Study Of The Efficacy And Safety Of Dapoxetine HCl In The Treatment Of Rapid Ejaculation

Resource links provided by NLM:

Drug Information available for: Dapoxetine Dapoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Enrollment:	1294
Study Start Date:	June 2003
Study Completion Date:	June 2004

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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211107

Sponsors and Collaborators

Alza Corporation, DE, USA

Investigators

Study Director:

Alza Corporation Clinical Trial

ALZA

More Information

Additional Information:

A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Nov 8.

ClinicalTrials.gov Identifier:	NCT00211107 History of Changes
Other Study ID Numbers:	CR006088
Study First Received:	September 15, 2005
Last Updated:	May 18, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:

dapoxetine
rapid ejaculation
premature ejaculation
ejaculation

sexual dysfunction
orgasmic disorder
sexual intercourse

ClinicalTrials.gov processed this record on February 09, 2012