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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Uterine Fibroids, Heavy Menstrual Bleeding

In brief

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.

Key facts

Study ID

NCT02691494

Run by

AbbVie

People needed

378

Starts

2016-02-03

Expected to finish

2019-01-23

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older, up to 51. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Choice Research, LLC /ID# 150988 — Dothan, Alabama, United States
• Brown, Pearson, Guepet Gynecology /ID# 151020 — Fairhope, Alabama, United States
• Mobile, Ob-Gyn, P.C. /ID# 144294 — Mobile, Alabama, United States
• Mesa Obstetricians and Gynecol /ID# 149139 — Mesa, Arizona, United States
• Visions Clinical Research-Tucs /ID# 151017 — Tucson, Arizona, United States
• Core Healthcare Group /ID# 151016 — Cerritos, California, United States
• Diagnamics Inc. /ID# 152469 — Encinitas, California, United States
• HCP Clinical Research LLC /ID# 154434 — Huntington Beach, California, United States
• Alliance Research Centers /ID# 149752 — Laguna Hills, California, United States
• University of California, Los Angeles /ID# 149760 — Los Angeles, California, United States
• Futura Research, Inc. /ID# 149759 — Norwalk, California, United States
• Farid Yasharpour MD Medical Co /ID# 149770 — San Fernando, California, United States
• Clinical Trial Investigators /ID# 152470 — Tustin, California, United States
• Bayview Research Group LLC /ID# 153799 — Valley Village, California, United States
• Emerson Clinical Research Inst /ID# 152348 — Washington D.C., District of Columbia, United States
• Ideal Clinical Research Inc. /ID# 149757 — Aventura, Florida, United States
• Seffner Premier Health Care, P /ID# 167480 — Brandon, Florida, United States
• Olympian Clinical Research /ID# 149756 — Clearwater, Florida, United States
• KO Clinical Research, LLC /ID# 144299 — Fort Lauderdale, Florida, United States
• University of Florida /ID# 149751 — Gainesville, Florida, United States
• Solutions Through Adv Rch /ID# 151021 — Jacksonville, Florida, United States
• Meridien Research /ID# 167100 — Kenneth City, Florida, United States
• Invictus Clinical Research Group,LLC /ID# 141859 — Miami, Florida, United States
• Precision Research Org, LLC /ID# 144335 — Miami Lakes, Florida, United States
• Alabama Clinical Therapeutics, LLC /ID# 152258 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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