A Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Uterine Fibroids
Phase of Trial: Phase II
Latest Information Update: 10 Mar 2017
At a glance
- Drugs Fezolinetant (Primary)
- Indications Uterine leiomyoma
- Focus Therapeutic Use
- Sponsors Ogeda
- 10 Mar 2017 This trial was completed in Austria(End date: 05 Dec 2016).
- 26 Feb 2017 This trial was completed in Belgium and Germany (End date: 05 Dec 2016).
- 19 Jul 2016 According to an Euroscreen media release, the company has opened an Investigational Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to conduct pivotal efficacy and safety assessments to evaluate ESN364 in Phase II studies for the treatment of menopausal hot flashes, poly cystic ovary syndrome and uterine fibroids.