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

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 3


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

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 at the end of the treatment period (Week 12) for both doses of dapoxetine

Secondary Outcome Measures:

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


Enrollment:	1320
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). 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211094

Sponsors and Collaborators

Alza Corporation, DE, USA

Investigators


Study Director:	Alza Corporation Clinical Trial	ALZA

More Information

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.

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. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.


ClinicalTrials.gov Identifier:	NCT00211094 History of Changes
Other Study ID Numbers:	CR006091
Study First Received:	September 15, 2005
Last Updated:	February 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:


dapoxetine premature ejaculation ejaculation	sexual dysfunction orgasmic disorder sexual intercourse

Additional relevant MeSH terms:


Premature Ejaculation Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016