Proof of Mechanism in ELT (PoM)

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Premature Ejaculation

Treatments

Drug: Placebo

Drug: GSK958108

Study type

Interventional

Funder types

Industry

Identifiers

NCT00861484

111155

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.