Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Condition: Heavy Uterine Bleeding; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Intervention: Elagolix; Placebo; Estradiol/Norethindrone acetate (E2/NETA); Estradiol; Progesterone
Intervention description: Elagolix tablets; Matching placebo tablets; A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.; 1.0 mg micronized estradiol tablets administered once a day; Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: Female
Minimum age: 20 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Uterine Fibroids; Heavy Uterine Bleeding; Elagolix; Menorrhagia; ABT-620; Leiomyomata; Elagolix sodium

Summary:

      The purpose of this proof-of-concept study is to assess the safety and effectiveness of
      elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to
      reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with
      heavy uterine bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a pre-menopausal female 20 to 49 years of age.

          -  Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed
             by a central reader and verification that a fibroid present met the following
             criteria:

               -  At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small
                  fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately
                  22 weeks' gestation) as documented by a centrally read ultrasound.

               -  Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified
                  subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).

               -  Ultrasound procedures were performed during the Screening Period, and subjects
                  were not randomized until the investigator reviewed the central reader results
                  verifying the inclusion requirements.

          -  Subject has a history of regular menstrual cycles between 24 to 35 days.

          -  Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by
             blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline
             hematin method.

        Exclusion Criteria:

          -  Subject has had a myomectomy, uterine artery embolization, or high intensity focused
             ultrasound for fibroid destruction within 1 year prior to randomization or any history
             of endometrial ablation.

          -  Subject has a history of osteoporosis or other metabolic bone disease.

          -  Subject shows evidence of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including
             depression), or neurologic diseases or any uncontrolled medical illness such as
             uncontrolled type 2 diabetes.

          -  Subject has a history of clinically significant condition(s) including but not limited
             to:

               -  Endometriosis

               -  Epilepsy or seizures

               -  Type 1 diabetes

               -  Any cancer (except basal cell carcinoma of the skin), including breast or ovarian
                  cancer or subject has taken any systemic cancer chemotherapy