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

Completed · Phase 3 · Has a placebo group

Conditions studied: Heavy Menstrual Bleeding, Uterine Fibroids

In brief

This randomized multicenter 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 was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

Key facts

Study ID

NCT03271489

Run by

AbbVie

People needed

478

Starts

2017-09-13

Expected to finish

2024-06-28

Last updated by the study team

2025-07-22

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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) or 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.

You may not qualify if…

• 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.

Where it is running

• Vision's Clinical Research-Tucson /ID# 161508 — Tucson, Arizona, United States
• Eclipse Clinical Research /ID# 161516 — Tucson, Arizona, United States
• Duplicate_Core Healthcare Group /ID# 160858 — Cerritos, California, United States
• Diagnamics Inc. /ID# 160950 — Encinitas, California, United States
• HRC Fertility /ID# 161493 — Encino, California, United States
• SC Clinical Research /ID# 164395 — Garden Grove, California, United States
• Duplicate_Duplicate_Marvel Clinical Research /ID# 167297 — Huntington Beach, California, United States
• Grossmont Ctr Clin Research /ID# 165120 — La Mesa, California, United States
• Olympia Clinical Trials /ID# 201562 — Los Angeles, California, United States
• National Research Institute /ID# 160952 — Los Angeles, California, United States
• Futura Research, Org /ID# 160924 — Montebello, California, United States
• California Medical Research Associates /ID# 161481 — Northridge, California, United States
• Northern California Research /ID# 161561 — Sacramento, California, United States
• Precision Research Institute - San Diego /ID# 163069 — San Diego, California, United States
• MD Strategies Research Centers /ID# 161544 — San Diego, California, United States
• Health care Affiliates Medical Group /ID# 163324 — Santa Ana, California, United States
• Alta California Medical Group /ID# 163564 — Simi Valley, California, United States
• Upland Clinical Research /ID# 164528 — Upland, California, United States
• Bayview Research Group LLC /ID# 161484 — Valley Village, California, United States
• Advanced RX Clinical Research /ID# 161599 — Westminster, California, United States
• Emerson Clinical Research Inst /ID# 162181 — Washington D.C., District of Columbia, United States
• James A. Simon, MD, PC /ID# 160931 — Washington D.C., District of Columbia, United States
• Women's Health Partners /ID# 203577 — Boca Raton, Florida, United States
• David Lubetkin MD LLC /ID# 203578 — Boca Raton, Florida, United States
• Noble Clinical Research /ID# 166949 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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