A Phase 3 trial of Proellex® (telapristone acetate) for the treatment of symptomatic uterine fibroids
Phase of Trial: Phase III
Latest Information Update: 31 Jan 2017
At a glance
- Drugs Telapristone (Primary)
- Indications Uterine leiomyoma
- Focus Therapeutic Use
- 31 Jan 2017 According to a Repros Therapeutics media release, the FDA has granted meeting to discuss the Phase 3 requirements to demonstrate both efficacy and safety for the development of Proellex for the treatment of uterine fibroids, the meeting is scheduled to occur before the end of April 2017.
- 20 Dec 2016 New trial record
- 12 Dec 2016 According to a Repros Therapeutics media release, company has requested a meeting with the FDA to discuss requirements for this trial and anticipates a meeting will be scheduled during the first half of 2017.