Conditions: Premature Ejaculation
Keywords: Proof of Concept Double Blind
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.

Detailed description:

Arms:
arm 1: placebo arm 2: 50 mg GSK557296 arm 3: 150 mg GSK557296

Interventions: intervention 1: GSK557296 intervention 2: GSK557296 intervention 3: placebo
Intervention descriptions: intervention 1: 50 mg GSK557296 intervention 2: 150 mg GSK557296 intervention 3: placebo

Protocol document: