A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

Inclusion Criteria:

• Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].
• Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin method.
• Participant has negative urine and/or serum pregnancy test in 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) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.
• Participant has history of osteoporosis, osteopenia, 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.