Clinical Trial: Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

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

Official Title: Evaluation of Single Dose and Steady State Pharmacokinetics of Flibanserin Postmenopausal Women With Hypoactive Sexual Desire Disorder

Brief Summary: This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.

Detailed Summary:
Sponsor: Sprout Pharmaceuticals, Inc

Current Primary Outcome:

• Flibanserin: Area Under the Curve; AUC_0-∞ [ Time Frame: 8 days ]
  Geometric mean of the AUC_0-∞ of Flibanserin
• Flibanserin: AUC τ,ss [ Time Frame: 8 days ]
  Geometric mean of the AUC τ,ss of Flibanserin
• Flibanserin: Cmax (Peak Concentration) [ Time Frame: 8 days ]
  Geometric mean of the Cmax of Flibanserin
• Flibanserin: Cmax,ss [ Time Frame: 8 days ]
  Geometric mean of the Cmax,ss of Flibanserin
• Flibanserin: Tmax,ss [ Time Frame: 8 days ]
  Median of the tmax,ss of Flibanserin

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sprout Pharmaceuticals, Inc

Dates:
Date Received: August 24, 2010
Date Started: July 2010
Date Completion:
Last Updated: May 15, 2014
Last Verified: May 2014