12-Month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA.

Trial Profile

12-Month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA.

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2015

At a glance

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

    • 20 Dec 2015 Results published in the Annals of Pharmacotherapy
    • 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.
    • 14 Mar 2012 Sprout Pharmaceuticals added as an association as reported by ClinicalTrials.gov.
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