A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Phase of Trial: Phase III
Latest Information Update: 07 Mar 2018
At a glance
- Drugs KLH 2109 (Primary) ; Estradiol; Norethisterone
- Indications Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Acronyms PRIMROSE 2
- Sponsors ObsEva
- 14 Nov 2017 According to an ObsEva media release, the company expects to complete patient enrollment in late 2018.
- 25 Apr 2017 According to an ObsEva media release, the first clinical centers are opened and started the recruitment of patients.
- 25 Apr 2017 Status changed from not yet recruiting to recruiting, according to an ObsEva media release.