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

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

NCT02654054

Run by

AbbVie

People needed

413

Starts

2015-12-22

Expected to finish

2018-12-12

Last updated by the study team

2020-06-29

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

• University of South Alabama /ID# 148763 — Mobile, Alabama, United States
• WCCT Global, LLC /ID# 145666 — Costa Mesa, California, United States
• American Clinical Trials /ID# 147374 — Hawaiian Gardens, California, United States
• Grossmont Ctr Clin Research /ID# 144011 — La Mesa, California, United States
• Long Beach Clinical Trial Serv /ID# 152424 — Long Beach, California, United States
• National Research Institute /ID# 151629 — Los Angeles, California, United States
• University of California, Los Angeles /ID# 144107 — Los Angeles, California, United States
• Beach OBGYN Medical Group /ID# 151414 — Newport Beach, California, United States
• Advanced RX Clinical Research /ID# 149168 — Westminster, California, United States
• Bluebird Clinical Trials, LLC /ID# 144843 — Colorado Springs, Colorado, United States
• Advanced Women's Health Institution /ID# 144108 — Greenwood Village, Colorado, United States
• Medstar Health Research Institute /ID# 145933 — Washington D.C., District of Columbia, United States
• James A. Simon, MD, PC /ID# 139675 — Washington D.C., District of Columbia, United States
• Helix Biomedics, LLC /ID# 147114 — Boynton Beach, Florida, United States
• Brandon Premier Health Care, PA /ID# 153130 — Brandon, Florida, United States
• Florida Clin Res Group /ID# 139811 — Ckearwater, Florida, United States
• Universal Clinical Research A /ID# 139742 — Doral, Florida, United States
• Clinical Physiology Associates /ID# 139736 — Fort Myers, Florida, United States
• Meridien Research /ID# 139663 — Kenneth City, Florida, United States
• Altus Research, Inc /ID# 139662 — Lake Worth, Florida, United States
• South Florida Wellness & Clinic /ID# 143558 — Margate, Florida, United States
• LCC Medical Research Institute /ID# 143551 — Miami, Florida, United States
• Healthcare Clinical Data, Inc /ID# 139650 — Miami, Florida, United States
• Ocean Blue Med Research Ctr /ID# 139826 — Miami, Florida, United States
• Summers, Birmingham, AL /ID# 139684 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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