LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Heavy Menstrual Bleeding; Uterine Fibroid
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Relugolix; Estradiol/norethindrone acetate; Relugolix placebo; Estradiol/norethindrone acetate placebo
Intervention description: Relugolix (40 mg) tablet administered orally once daily.; E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.; Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.; E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Relugolix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 382.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine Fibroid; Heavy Menstrual Bleeding; Menstrual Blood Volume

Summary:

      The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a
      day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared
      with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Premenopausal female aged 18 to 50 years old (inclusive) on the day of signing and
             dating 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, by
             participant 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/or
             transabdominal ultrasound performed during the screening period.

          4. Has heavy menstrual bleeding associated with uterine fibroids as evidenced by an MBL
             of ≥ 160 milliliter (mL) during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles as
             measured by the alkaline hematin method during the screening period.

        Key Exclusion Criteria:

          1. Has transvaginal and/or transabdominal ultrasound during the screening period
             demonstrating pathology other than uterine fibroids that could be responsible for or
             contributing to the participant'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 that
             precludes 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 low
             traumatic (from the standing position) or atraumatic fracture (toe, finger, skull,
             face and ankle fractures are allowed). A history of successfully treated
             hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the
             participant'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 D
             preparations to treat bone mineral density loss.

          6. Has been a participant in an investigational drug or device study within the 1 month
             prior to the first screening visit.