A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation
| Status: | Archived |
|---|---|
| Conditions: | Premature Ejaculation, Psychiatric |
| Therapuetic Areas: | Nephrology / Urology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2009 |
| End Date: | April 2011 |
A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men With Premature Ejaculation
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior
efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an
8 week study period compared to placebo in men with primary premature ejaculation. An
assessment of the safety and tolerability of all doses of GSK557296 will be performed as
well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline
and at the end of the 8 weeks of treatment. During the active treatment period study
participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20
doses for both 4 week intervals.
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sites
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1 Medical Center Drive
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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