Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210613
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-13
Brief Title:
A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 studyThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None