Proof of Mechanism in ELT

Premature Ejaculation Clinical Trial

— PoM  

Official title:

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 Patient Suffering From Premature Ejaculation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861484
• Other study ID #: 111155
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2009
• Last updated: June 13, 2017
• Start date: November 26, 2008
• Est. completion date: December 11, 2009

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 11, 2009
• Est. primary completion date: December 11, 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• GSK958108
Coated Tablets 1 mg
• Placebo
Coated tablets

Locations

Country	Name	City	State
Italy	GSK Investigational Site	Verona	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli		50 minutes
Secondary	Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination		8 weeks
Secondary	Blood concentration of GSK958108 at different timepoints		From predose to 30 hours post-dose

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 111155 can be found on the GSK Clinical Study Register.