A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Phase of Trial: Phase III
Latest Information Update: 10 Oct 2017
At a glance
- Drugs Ulipristal (Primary)
- Indications Uterine haemorrhage; Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Acronyms Venus II
- Sponsors Actavis; Allergan
- 10 Oct 2017 According to an Allergan media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ulipristal acetate, for the treatment of abnormal uterine bleeding in women with uterine fibroids with Prescription Drug User Fee Act (PDUFA) action date to occur in the first half of 2018.
- 28 Jun 2017 Status changed from active, no longer recruiting to completed.
- 17 Jan 2017 Results published in the Allergan Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History