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.
Phase of Trial: Phase III
Latest Information Update: 18 Aug 2015
At a glance
- Drugs Flibanserin (Primary)
- Indications Decreased libido
- Focus Registrational; Therapeutic Use
- Sponsors Sprout Pharmaceuticals
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History