Proof of Mechanism in ELT (PoM)

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

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

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Drug: GSK958108; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Italy
  • Veneto
    • Verona, Veneto, Italy, 37134
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK958108 3 mg; Experimental	Drug: GSK958108; Coated Tablets 1 mg
Placebo Comparator: Placebo of GSK958108; Placebo	Drug: Placebo; Coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli	50 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination	8 weeks
Blood concentration of GSK958108 at different timepoints	From predose to 30 hours post-dose

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2008
• Primary Completion (Actual): December 11, 2009
• Study Completion (Actual): December 11, 2009

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimate): March 13, 2009

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: 111155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: 111155
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register