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

Phase 2

Completed

Conditions: premature ejaculation
10038612

Registration Number: NL-OMON35560

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Males with primary PE, according to the ISSM Consensus Definition.
2. Stable heterosexual relationship.
3. Aged between 18 and 54 years.
4. The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
5. The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.

Exclusion Criteria

Erectile dysfunction (defined as IIEF-EF domain score < 22).
Active or recent (< 6 months) history of prostatitis.
Presence of penile anatomical abnormalities.
Prior implantation of penile implant for erectile dysfunction.
Primary hypoactive sexual desire.
Spinal cord injury.
History of seizures, within last 6 months.
History of prostate cancer treated or untreated.
History of prostatectomy or prostate procedures for any cause.
Cardiac arrhythmia.
Any condition which would preclude sexual activity.
Labvalues outside normal range.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine if an on demand dosing of 50 or 150 mg of GSK557296 demonstrates<br /><br>superior efficacy with respect to duration of IELT during an 8 week study period<br /><br>compared to placebo in men with premature ejaculation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess safety and tolerability of 50 mg and 150 mg of GSK557296.<br /><br>To assess change in the Index of Premature Ejaculation (IPE) from baseline and<br /><br>at<br /><br>the end of the 8 weeks of treatment<br /><br>To characterize the pharmacokinetics of GSK557296 in men with premature<br /><br>ejaculation.<br /><br>To characterize the dose/exposure response relationship using PK/PD modeling, as<br /><br>data permit.</p><br>