Premature ejaculation MedDRA version: 9.1 Level: LLT Classification code 10036596 Term: Premature ejaculation
Conditions
Interventions
Product Code: GSK958108
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: GSK958108
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical fo
Sponsors
GLAXO SMITHKLINE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male between 18 and 50 years of age -Body weight ≥ 50 kg (110 lbs) and BMI within the range 19.0 ? 29.9 kg/m2 inclusive) -Heterosexual orientation -Long term symptoms of PE that meet DSM-IV-TR criteria for PE -Premature ejaculation is not due to any other concomitant medical condition -Self-reported moderate or severe primary PE prior to screening -The patient has a baseline ELT less than 3 minutes -The subject has a visual acuity that is equivalent to 20/30 in each eye with appropriate correction if needed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Erectile Dysfunction subjects should have Erectile Function domain of International Index of Erectile Function questionnaire >26 or normal -The subject has a history of migraine -The subject has a history of Psychiatric illness, except for those symptoms related to their PE -Any history of suicidal attempts or behaviour -The subject has a history of any eye disorder or is colour blind, excluding myopia and presbyopia -History of long QT syndrome (personal or family) or other clinically significant cardiac disease -Subject smokes more than 10 cigarettes per day -Regular use of any PDE-5 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of a single oral dose of GSK958108, on ejaculatory latency time (ELT) as measured in the masturbation model.;Secondary Objective: To assess the safety and tolerability of a single oral dose of GSK958108 To investigate the pharmacokinetics of GSK958108;Primary end point(s): To evaluate the effect of a single oral dose of GSK958108, on ejaculatory latency time (ELT) as measured in the masturbation model. | — |
Countries
Italy
Outcome results
None listed