Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
Phase 1
Completed
- Conditions
- Sexual Dysfunctions, Psychological
- Interventions
- Registration Number
- NCT01188603
- Lead Sponsor
- Sprout Pharmaceuticals, Inc
- Brief Summary
This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description flibanserin flibanserin 100 mg dose every evening flibanserin 100 mg dose every evening
- Primary Outcome Measures
Name Time Method Flibanserin: Cmax (Peak Concentration) 8 days Geometric mean of the Cmax of Flibanserin
Flibanserin: Cmax,ss 8 days Geometric mean of the Cmax,ss of Flibanserin
Flibanserin: Tmax,ss 8 days Median of the tmax,ss of Flibanserin
Flibanserin: Area Under the Curve; AUC_0-∞ 8 days Geometric mean of the AUC_0-∞ of Flibanserin
Flibanserin: AUC τ,ss 8 days Geometric mean of the AUC τ,ss of Flibanserin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
511.146.01005 Boehringer Ingelheim Investigational Site
🇺🇸Wichita, Kansas, United States
511.146.01001 Boehringer Ingelheim Investigational Site
🇺🇸Kalamazoo, Michigan, United States
511.146.01004 Boehringer Ingelheim Investigational Site
🇺🇸Knoxville, Tennessee, United States
511.146.01003 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States