A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation
The primary purpose of the study is to assess the possible withdrawal effects after abruptly stopping daily therapy with dapoxetine compared with continuing daily therapy in men with premature ejaculation (PE).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Withdrawal Effects of Chronic Daily and As-Needed Dosing With Dapoxetine in the Treatment of Premature Ejaculation|
- Incidence of withdrawal symptoms (defined by a checklist of signs and symptoms associated with stopping the therapy) at Weeks 9, 10, and 11 of treatment
- Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study through Week 11; adverse incidence and severity throughout study and follow up (Week 12)
|Study Start Date:||November 2004|
|Study Completion Date:||August 2005|
Premature ejaculation (PE) is a form of male sexual dysfunction. A measure of withdrawal effects associated with stopping therapy for PE is the Discontinuation-Emergent Signs and Symptoms (DESS), a series of questions for signs and symptoms experienced by the patient. This study of men with PE is a multicenter, randomized, double-blind trial consisting of 3 phases: pre-randomization phase (a screening visit and 1-week baseline period); 10-week double-blind treatment phase during which patients receive dapoxetine or placebo; and 2-week follow-up phase. The total duration of the study is approximately 13 weeks. During the double-blind phase patients receive study medication for once daily treatment and for use on as "as-needed" basis prior to sexual activity. After 9 weeks, some patients (half of the active patients) continue treatment with dapoxetine and other (another half of the active patients) are switched to placebo for the last week of therapy, abruptly stopping the study drug. Assessments of effectiveness include the incidence of withdrawal symptoms, assessed by changes in DESS; control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at specified intervals during the study. Safety assessments include the incidence, severity, and type of adverse events throughout the study, as well as laboratory tests and questionnaires to monitor sexual function at specified times during the study.The study hypothesis is that abruptly stopping treatment with dapoxetine in men with PE does not result in an increase in withdrawal symptoms (as assessed by DESS), compared with the men who stay with the treatment. Oral tablets of dapoxetine (60 milligrams) taken once daily and also as needed during 10 weeks of treatment. No more than 1 tablet for daily treatment and 1 as-needed tablet within a 24-hour period.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|