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

Phase 4

Completed

• Conditions: Uterine Fibroids
• Interventions: Drug: Placebo; Drug: Elagolix

• Registration Number: NCT03886220
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Start: 2019-04-12
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-28
• Status Verified: 2022-03
• Results First Submitted: 2022-03-04
• Results First Submitted QC: 2022-03-04
• Last Update Submitted: 2022-03-04
• Results First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo QD
Elagolix 150 mg	Elagolix	Elagolix 150 mg once daily (QD)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month	From Month 0 (Baseline) to Final Month (up to Month 6)	Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and; * 50% or greater reduction in MBL volume from Baseline to the Final Month.; Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.

Trial Locations

Locations (48)

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

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