An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed · Phase 3

Conditions studied: Uterine Fibroids, Heavy Menstrual Bleeding

In brief

This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

Key facts

Study ID

NCT02925494

Run by

AbbVie

People needed

433

Starts

2016-09-14

Expected to finish

2019-03-22

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…

• Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
• Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
• Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
• Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.

You may not qualify if…

• Participant met criteria for removal from therapy in her respective Pivotal Study.
• Participant is planning a pregnancy within the next 18 months.
• Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
• Participant has any new medical conditions that may be unsuitable for participation.
• Participant is using any systemic corticosteroids for over 14 days 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

• Alabama Clinical Therapeutics, LLC /ID# 153336 — Birmingham, Alabama, United States
• Choice Research, LLC /ID# 153492 — Dothan, Alabama, United States
• Brown, Pearson, Guepet Gynecology /ID# 153278 — Fairhope, Alabama, United States
• University of South Alabama /ID# 153415 — Mobile, Alabama, United States
• Mobile, Ob-Gyn, P.C. /ID# 153442 — Mobile, Alabama, United States
• Mesa Obstetricians and Gynecol /ID# 153269 — Mesa, Arizona, United States
• Core Healthcare Group /ID# 153282 — Cerritos, California, United States
• Diagnamics Inc. /ID# 153347 — Encinitas, California, United States
• Grossmont Ctr Clin Research /ID# 153324 — La Mesa, California, United States
• Futura Research, Inc. /ID# 153345 — Norwalk, California, United States
• Farid Yasharpour MD Medical Co /ID# 153482 — San Fernando, California, United States
• Advanced Women's Health Institution /ID# 153401 — Greenwood Village, Colorado, United States
• Medstar Health Research Institute /ID# 153321 — Washington D.C., District of Columbia, United States
• Emerson Clinical Research Inst /ID# 162755 — Washington D.C., District of Columbia, United States
• James A. Simon, MD, PC /ID# 153323 — Washington D.C., District of Columbia, United States
• Helix Biomedics, LLC /ID# 153440 — Boynton Beach, Florida, United States
• Brandon Premier Health Care, PA /ID# 165791 — Brandon, Florida, United States
• Florida Fertility Institute /ID# 153308 — Clearwater, Florida, United States
• Omega Research Consultants, LLC /ID# 153381 — DeBary, Florida, United States
• KO Clinical Research, LLC /ID# 153198 — Fort Lauderdale, Florida, United States
• Clinical Physiology Assoc. /ID# 153444 — Fort Myers, Florida, United States
• Solutions Through Adv Rch /ID# 153283 — Jacksonville, Florida, United States
• Meridien Research /ID# 153310 — Kenneth City, Florida, United States
• Altus Research, Inc /ID# 153307 — Lake Worth, Florida, United States
• Alabama Clinical Therapeutics, LLC /ID# 153217 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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