Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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.

Key Inclusion Criteria:

- Premenopausal woman at screening.

- Body Mass Index ≥ 18 kg/m2.

- Menstrual cycles ≥ 21 days and ≤ 40 days.

- Presence of uterine fibroids.

- Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening
using the alkaline hematin method.

Key Exclusion Criteria:

- 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.