Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229073
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-27
Brief Title:
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With 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-Group Study Of The Efficacy And Safety Of Dapoxetine In The Treatment Of Subjects With Premature Ejaculation
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time IELT compared with placebo in men with premature ejaculation PE
Detailed Description:
Premature ejaculation PE is a form of male sexual dysfunction An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time IELT This is a multicenter placebo-controlled double-blind randomized parallel-group study in men with PE The study will consist 3 phases pre-randomization phase a screening visit and a 4-week baseline period 24-week double-blind treatment phase during which patients will receive dapoxetine or placebo for use on an as-needed basis and 1-week double-blind withdrawal phase dapoxetine or placebo with a post-study telephone contact approximately 2 weeks after the end of treatment The total duration of the study is approximately 31 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 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 and follow up Week 27 as well as laboratory tests and questionnaires to monitor possible changes in mood anxiety motor responses and sexual function at specified times during the study The study hypothesis is that treatment for 24 weeks with dapoxetine prolongs intravaginal ejaculatory latency time compared with placebo in men with PE Oral tablets of dapoxetine 30 milligramsmg or 60mg or placebo taken as needed during 24 weeks of treatment No more than 1 dose 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