Drug: Placebo + Placebo Add-back / Placebo tablets and Placebo Add-back for oral administration once daily
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids. Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.
- the subject is pregnant or breast-feeding or is planning a pregnancy within the
duration of the treatment period of the study.
- history of uterus surgery that would interfere with the study.
- the subject's condition is so severe that she will require surgery within 6 months
regardless of the treatment provided.
- undiagnosed abnormal uterine bleeding.
- significant risk of osteoporosis or history of, or known osteoporosis or other
metabolic bone disease.
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