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A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States

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Trial Profile

A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 May 2018

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At a glance

  • Drugs Flibanserin (Primary)
  • Indications Decreased libido; Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Sponsors Sprout Pharmaceuticals

    • Most Recent Events

    • 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.
    • 17 Feb 2015 Based on data from this trial, a driving study, a pharmacokinetic study and two other pivotal phase III trials, the NDA for flibanserin in premenopausal women has been resubmitted to the US FDA, according to a Sprout Pharmaceuticals media release.
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