A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America

Trial Profile

A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 50mg Every Evening and Flibanserin 100mg Every Evening in Women With Hypoactive Sexual Desire Disorder in North America

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2016

At a glance

  • Drugs Flibanserin (Primary)
  • Indications Decreased libido; Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Acronyms VIOLET
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 20 Dec 2015 Results published in the Annals of Pharmacotherapy
    • 18 Aug 2015 According to a Sprout Pharmaceuticals media release, the US FDA has approved flibanserin 100 mg (Addyi) for the treatment of acquired generalized hypoactive sexual desire disorder in premenopausal women.
    • 04 Jun 2015 According to a Sprout Pharmaceuticals media release, the FDA advisory committee has recommended for approval flibanserin (ADDYI) for the treatment of hypoactive sexual desire disorder in premenopausal women.
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