LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Key Inclusion Criteria:

1. Premenopausal female aged 18 to 50 years old (inclusive) on the day of signing anddating the informed consent form.
2. Has regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of 1 menstrual period until the start of the next, byparticipant history for at least 3 months prior to the first screening visit.
3. Has a diagnosis of uterine fibroids that is confirmed by a transvaginal and/ortransabdominal ultrasound performed during the screening period.
4. Has heavy menstrual bleeding associated with uterine fibroids as evidenced by an MBLof ≥ 160 milliliter (mL) during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles asmeasured by the alkaline hematin method during the screening period.

Key Exclusion Criteria:

1. Has transvaginal and/or transabdominal ultrasound during the screening perioddemonstrating pathology other than uterine fibroids that could be responsible for orcontributing to the patient's heavy menstrual bleeding.
2. Has known rapidly enlarging uterine fibroids in the opinion of the investigator.
3. Has a weight that exceeds the weight limit of the DXA scanner or has a condition thatprecludes an adequate DXA measurement at the lumbar spine and proximal femur.
4. Has a history of or currently has osteoporosis, or other metabolic bone disease,hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or lowtraumatic (from the standing position) or atraumatic fracture (toe, finger, skull,face and ankle fractures are allowed). A history of successfully treatedhyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if theparticipant's bone mineral density is within normal limits.
5. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone,teriparatide, denosumab, or any medication other than calcium and vitamin Dpreparations to treat bone mineral density loss.
6. Has been a participant in an investigational drug or device study within the 1 monthprior to the first screening visit.