Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
Condition: Uterine Fibroids; Heavy Menstrual Bleeding
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Elagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
Intervention description: Film-coated tablets; Placebo capsules; Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.; Film-coated placebo tablets
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 378.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Elagolix; Elagolix Sodium; Heavy uterine bleeding; Heavy menstrual bleeding (HMB); Leiomyomata; Menorrhagia; ABT-620; Elagolix + E2/NETA (Elagolix + Norethindrone acetate)

Summary:

      This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in
      combination with estradiol/norethindrone acetate for the management of heavy menstrual
      bleeding associated with uterine fibroids in premenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a premenopausal female at the time of Screening.

          -  Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound
             (transabdominal ultrasound/transvaginal ultrasound).

          -  Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by
             menstrual blood loss > 80 mL during each of two screening menses as measured by the
             alkaline hematin method.

          -  Subject has negative urine and/or serum pregnancy test in Screening and just prior to
             first dose.

          -  Subject has an adequate endometrial biopsy performed during Screening, the results of
             which show no clinically significant endometrial pathology.

        Exclusion Criteria:

          -  Subject has screening pelvic ultrasound or saline infusion sonohysterography results
             that show a clinically significant gynecological disorder.

          -  Subject has history of osteoporosis or other metabolic bone disease.

          -  Subject has clinically significant abnormalities in clinical chemistry, hematology, or
             urinalysis.

          -  Subject has a history of major depression or post-traumatic stress disorder (PTSD)
             within 2 years of screening, OR a history of other major psychiatric disorder at any
             time (e.g., schizophrenia, bipolar disorder).

          -  Subject is using any systemic corticosteroids for over 14 days within 3 months prior
             to Screening or is likely to require treatment with systemic corticosteroids during
             the course of the study. Over the counter and prescription topical, inhaled,
             intranasal or injectable (for occasional use) corticosteroids are allowed.