Text Size

Proof of Mechanism in ELT (PoM)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00861484
First received: March 12, 2009
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Premature Ejaculation
 Drug: GSK958108
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli [ Time Frame: 50 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Blood concentration of GSK958108 at different timepoints [ Time Frame: From predose to 30 hours post-dose ] [ Designated as safety issue: No ]

Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK958108 3 mg Drug: GSK958108
Coated Tablets 1 mg
Placebo Comparator: Placebo of GSK958108 Drug: Placebo
Coated tablets

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861484

Locations
Italy
GSK Investigational Site
Verona, Veneto, Italy, 37134
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00861484     History of Changes
Other Study ID Numbers: 111155
Study First Received: March 12, 2009
Last Updated: October 19, 2010
Health Authority: Italy: Agenzia Italiana del Farmaco

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013