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

Completed · Phase 4 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT03886220

Run by

AbbVie

People needed

82

Starts

2019-04-12

Expected to finish

2021-04-28

Last updated by the study team

2022-03-31

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ACCEL Research Sites /ID# 209714 — Birmingham, Alabama, United States
• University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581 — Birmingham, Alabama, United States
• Unity Health- Searcy Medical Center /ID# 210905 — Searcy, Arkansas, United States
• Grossmont Ctr Clin Research /ID# 217690 — La Mesa, California, United States
• Women's Health Care Research Corp /ID# 211472 — San Diego, California, United States
• Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764 — Fort Myers, Florida, United States
• Caceres Specialized Gynecology /ID# 214956 — Kissimmee, Florida, United States
• LCC Medical Research Institute /ID# 213765 — Miami, Florida, United States
• Genoma Research Group, Inc /ID# 213771 — Miami, Florida, United States
• A Premier Medical Research of FL /ID# 214947 — Orange City, Florida, United States
• GCP Clinical Research, LLC /ID# 218742 — Tampa, Florida, United States
• Comprehensive Clinical Trials LLC /ID# 217177 — West Palm Beach, Florida, United States
• Georgia Research for Women /ID# 211321 — Atlanta, Georgia, United States
• Atlanta Women's Research Institute /ID# 217745 — Atlanta, Georgia, United States
• Medisense Inc /ID# 217750 — Atlanta, Georgia, United States
• Women's Health of Augusta /ID# 214995 — Augusta, Georgia, United States
• Midtown OBGYN North /ID# 209391 — Columbus, Georgia, United States
• Journey Medical Research Institute - Snellville /ID# 217309 — Snellville, Georgia, United States
• Affinity Clinical Research /ID# 215252 — Oak Brook, Illinois, United States
• Clinical Trials Management, LLC - Covington /ID# 215020 — Covington, Louisiana, United States
• Southern Clinical Research A /ID# 213732 — Metairie, Louisiana, United States
• Johns Hopkins University /ID# 211135 — Baltimore, Maryland, United States
• NECCR Fall River LLC /ID# 215009 — Fall River, Massachusetts, United States
• Excel Clinical Research /ID# 215936 — Las Vegas, Nevada, United States
• Manhattan Medical Research /ID# 213753 — New York, New York, United States

Full record on ClinicalTrials.gov

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