Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211094
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2005-09-15
Brief Title:
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Placebo-Controlled Double-blind Randomized Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Status:
COMPLETED
Status Verified Date:
2011-02
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 demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time IELT compared with placebo in men with premature ejaculation PE
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
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