``A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation.`` - ND

• Conditions: Premature ejaculation; MedDRA version: 9.1Level: LLTClassification code 10036596Term: Premature ejaculation

• Registration Number: EUCTR2008-005319-16-IT
• Lead Sponsor: GLAXO SMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-Male between 18 and 50 years of age -Body weight ≥ 50 kg (110 lbs) and BMI within the range 19.0 ? 29.9 kg/m2 inclusive) -Heterosexual orientation -Long term symptoms of PE that meet DSM-IV-TR criteria for PE -Premature ejaculation is not due to any other concomitant medical condition -Self-reported moderate or severe primary PE prior to screening -The patient has a baseline ELT less than 3 minutes -The subject has a visual acuity that is equivalent to 20/30 in each eye with appropriate correction if needed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Erectile Dysfunction subjects should have Erectile Function domain of International Index of Erectile Function questionnaire >26 or normal -The subject has a history of migraine -The subject has a history of Psychiatric illness, except for those symptoms related to their PE -Any history of suicidal attempts or behaviour -The subject has a history of any eye disorder or is colour blind, excluding myopia and presbyopia -History of long QT syndrome (personal or family) or other clinically significant cardiac disease -Subject smokes more than 10 cigarettes per day -Regular use of any PDE-5 inhibitors

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of a single oral dose of GSK958108, on ejaculatory latency time (ELT) as measured in the masturbation model.;Secondary Objective: To assess the safety and tolerability of a single oral dose of GSK958108 To investigate the pharmacokinetics of GSK958108;Primary end point(s): To evaluate the effect of a single oral dose of GSK958108, on ejaculatory latency time (ELT) as measured in the masturbation model.