Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211107
Status:
COMPLETED
Last Update Posted:
2011-05-19
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:
2010-03
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 An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time IELT This is a randomized double-blind study in men with PE 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 dapoxetine at one of two dosages or placebo for use on an as-needed basis The total duration of the study is approximately 14 weeks Patients and their partners are expected to attempt sexual intercourse at least 4 times during the baseline period and at least 6 times each month during the treatment phase Assessments of effectiveness include the average Intravaginal Ejaculatory Latency time IELT as measured by stopwatch during sexual intercourse for the treatment period 12 weeks 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 12 weeks vital sign measurements pulse and blood pressure and laboratory tests hematology chemistry urinalysis at monthly intervals 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 milligramsmg or 60mg taken as needed during 12 weeks of treatment No more than one 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