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VIOLET: Flibanserin in HSDD
NCT00360529Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2006
- Primary completion
- Apr 2008
- Countries
- 2
- Sponsor
- Sprout Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- flibanserin
- Conditions
- hypoactive sexual desire disorder (HSDD)
01
Overview
Phase 3, randomised, double-blind trial of flibanserin in hypoactive sexual desire disorder (HSDD) (3 arms), sponsored by Sprout Pharmaceuticals. Primary endpoints: Satisfying Sexual Event Monthly Change From Baseline at 24 weeks and Sexual Desire Monthly Change on Electronic Diary at 24 weeks. Started Jul 2006; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Flibanserin 50 mg
Flibanserin 50 mg q.h.s.
Flibanserin 100 mg
Flibanserin 100 mg q.h.s.
Placebo
Placebo q.h.s.
03
Who it enrols
Premenopausal women with generalized acquired HSDD, in a stable monogamous relationship for at least 1 year, using contraception. Excludes depression, other sexual disorders, and recent drug abuse.
04
Endpoints
Primary
Satisfying Sexual Event Monthly Change From Baseline
Sexual Desire Monthly Change on Electronic Diary
Secondary
Female Sexual Distress Scale - Revised Total Score Change
Female Sexual Distress Scale - Revised Question 13 Score Change
Female Sexual Functioning Index Desire Domain Score Change
Female Sexual Functioning Index Total Score Change
Patient Benefit Evaluation
05
Results
Not all primary endpoints met
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