Proof of Mechanism in ELT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-26

Study Completion Date

2009-12-11

Brief Summary

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The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE

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Detailed Description

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Conditions

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Premature Ejaculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK958108 3 mg

Experimental

Group Type EXPERIMENTAL

GSK958108

Intervention Type DRUG

Coated Tablets 1 mg

Placebo of GSK958108

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Coated tablets

Interventions

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GSK958108

Coated Tablets 1 mg

Intervention Type DRUG

Placebo

Coated tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation
* Baseline Ejaculation Latency time \< 3 minutes
* Subjects must agree to use a contraception methods as per protocol
* Body weight \> or = 50 kg and Body Mass Index within the range 19.0-29.9 Kg/m2
* Subject with normal visual acuity (with appropriate correction if needed)
* Subject able to cooperate in all study procedure including the eye examination with use of mydriatics

Exclusion Criteria

* Erectile dysfunction
* History of migraine
* Current clinically relevant abnormality
* History of psychiatric illness or suicidal attempts or behaviours
* History of any eye disorder or colour blind, excluding myopia and presbyopia
* Cardiac conduction disorder or other clinically significant cardiac disease
* Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests
* Regular consumption of alcohol
* History of sensitivity or intolerance to drugs
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice \[and/or pummelos, exotic citrus fruits, grapefruit hybrids\] from 7 days prior to the first dose of study medication
* Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication
* Participation in another clinical trial in the previous month
* Exposure to more than four new experimental drugs within the previous 12 months
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Unwillingness or inability to follow the procedures outlined in the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Verona, Veneto, Italy

Site Status

Countries

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Italy

Study Documents

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