Clinical Trial: A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double

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 Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: IELT: Time from vaginal penetration (start stopwatch) until ejaculation (stop stopwatch), assessed after every attempt at intercourse with 50mg, 150mg GSK557296 or placebo therapy, compared over all 8 weeks of treatment or until premature discontinuation [ Time Frame: 8 weeks of active treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IELT compared after each 4-week treatment period, or until premature discontinuation [ Time Frame: 4 week ]
  • IELT compared after the first dose of 50mg or 150mg GSK557296 or placebo [ Time Frame: 4 weeks ]
  • IELT change baseline compared after each 4-week treatment period and over all 8 weeks of 50mg or 150mg GSK557296 or placebo therapy, or until premature discontinuation [ Time Frame: 4-week, 8-week ]
  • IELT change from baseline compared after the first dose of 50mg or150mg GSK557296 or placebo [ Time Frame: 4 weeks ]
  • plasma pharmacokinetics (e.g. AUC, Tmax, Cmax) of GSK557296 will be obtained (as data permits). [ Time Frame: by week 4 ]
  • dose/exposure response relationship using PK/PD modeling for selected endpoints, as data permit. [ Time Frame: by week 4 ]
  • Tabulation of shifts in vital signs including ECGs as assessed by change from visits 1 and 2 compared to visits 3 and 4 for placebo and pooled GSK557296 treated groups and individual GSK557296 50mg and 150mg groups [ Time Frame: screening, week 4, week 8 and week 12 ]
  • Tabulations of shifts in serum laboratory data collected at visit 1 compared to visit 3 and 4 for placebo and pooled GSK557296 treated groups and individual GSK557296 50mg and 150mg group [ Time Frame: screening , week 8 ]
  • Tabulation of adverse events group by body system and preferred term, for placebo and pooled GSK557296 treated group and individual GSK557296 50mg and 150mg [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • IELT compared after the first dose of 50mg or 150mg GSK557296 or placebo [ Time Frame: 4 weeks ]
  • IELT change baseline compared after each 4-week treatment period and over all 8 weeks of 50mg or 150mg GSK557296 or placebo therapy, or until premature discontinuation. [ Time Frame: 4-week, 8-week ]
  • IELT change from baseline compared after the first dose of 50mg or150mg GSK557296 or placebo [ Time Frame: 4 weeks ]
  • plasma pharmacokinetics (e.g. AUC, Tmax, Cmax) of GSK557296 will be obtained (as data permits). [ Time Frame: by week 4 ]
  • dose/exposure response relationship using PK/PD modeling for selected endpoints, as data permit. [ Time Frame: by week 4 ]
  • Tabulation of shifts in vital signs including ECGs as assessed by change from visits 1 and 2 compared to visits 3 and 4 for placebo and pooled GSK557296 treated groups and individual GSK557296 50mg and 150mg groups. [ Time Frame: screening, week 4, week 8 and week 12 ]
  • Tabulations of shifts in serum laboratory data collected at visit 1 compared to visit 3 and 4 for placebo and pooled GSK557296 treated groups and individual GSK557296 50mg and 150mg group [ Time Frame: screening , week 8 ]
  • Tabulation of adverse events group by body system and preferred term, for placebo and pooled GSK557296 treated group and individual GSK557296 50mg and 150mg [ Time Frame: 12 weeks ]
  • IELT compared after each 4-week treatment period, or until premature discontinuation [ Time Frame: 4 week ]


Information By: GlaxoSmithKline

Dates:
Date Received: November 12, 2009
Date Started: December 2009
Date Completion:
Last Updated: January 27, 2017
Last Verified: January 2017