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
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 21 Dec 2018
At a glance
- Drugs Linzagolix (Primary) ; Estradiol; Norethisterone
- Indications Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Acronyms PRIMROSE 2
- Sponsors ObsEva
- 21 Dec 2018 According to an ObsEva media release, the company anticipate the primary endpoint read out of PRIMROSE 2 in Q4 2019.
- 21 Dec 2018 Status changed from recruiting to active, no longer recruiting, according to an ObsEva media release.
- 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.