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: 10 Dec 2018
At a glance
- Drugs Linzagolix (Primary)
- Indications Uterine leiomyoma
- Focus Therapeutic Use
- Acronyms PRIMROSE 1
- Sponsors ObsEva
- 07 Dec 2018 According to an ObsEva media release, six-month primary endpoint results from this study is expected in the second half of 2019.
- 16 May 2018 According to an ObsEva media release, enrolment completion in this trial is anticipated in Q1:2019.
- 14 Nov 2017 According to an ObsEva media release, the company expects to complete patient enrollment in late 2018.