Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Study Overview
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Brief Summary
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This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.

Official Title
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A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Conditions
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Heavy Menstrual Bleeding, Uterine Fibroids

Intervention / Treatment
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* Other: Elagolix Placebo
* Drug: E2/NETA
* Other: E2/NETA Placebo
* Drug: Elagolix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is a premenopausal female at the time of Screening. Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)]. Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method. Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose. Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology. Exclusion Criteria: Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder. Participant has history of osteoporosis or other metabolic bone disease. Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). Participant 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 intra-articular injectable (for occasional use) corticosteroids are allowed.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)<br>Elagolix plus estradiol (E2)/norethindrone acetate (NETA) | Drug: E2/NETA<br>* Capsules<br>Drug: Elagolix<br>* Tablets<br>* Other names: ABT-620 Elagolix sodium;|
| Placebo Comparator: Placebo<br>Placebo | Other: Elagolix Placebo<br>* Tablets<br>Other: E2/NETA Placebo<br>* Capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone Mineral Density (BMD) | Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA). | From Baseline through Month 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elagolix Sodium, Heavy Menstrual Bleeding (HMB), Heavy Uterine Bleeding, Leiomyomata, Menorrhagia, Elagolix + Norethindrone Acetate, Elagolix + E2/NETA, Elagolix, Safety, Efficacy, ABT-620