NCT01040208

12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Sprout Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.

Conditions

• Sexual Dysfunctions, Psychological
• Depression

Interventions

Type	Name	Description
DRUG	flibanserin 50 mg to 100 mg qhs	50 to 100mg qhs
DRUG	flibanserin 100 mg qhs	100mg qhs
DRUG	placebo 2 tablets qhs	50 mg placebo

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-12-29
• Last updated: 2016-08-24
• Results posted: 2016-08-24

Locations

42 sites across 1 country: United States