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Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America

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Trial Profile

Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2020

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At a glance

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

    • Most Recent Events

    • 20 Dec 2015 Results published in the Annals of Pharmacotherapy
    • 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.
    • 11 Dec 2013 Sprout Pharmaceuticals announced in a media release that it had received and appealed the FDA's Complete Response Letter (CRL) for flibanserin for the treatment of HSDD; the CRL was in response to resubmission of data from the Bouquet trials and others.

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