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

Uterine Fibroids Clinical Trial

Official title:

A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886220
• Other study ID #: M16-824
• Status: Completed
• Phase: Phase 4
• Start date: April 12, 2019
• Est. completion date: April 28, 2021

Study information

• Verified date: March 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 28, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Intervention

Drug:
• Elagolix
Oral; Tablet
• Placebo
Oral; Tablet

Locations

Country	Name	City	State
Puerto Rico	Emanuelli Research & Development Center LLC /ID# 212715	Arecibo
Puerto Rico	Puerto Rico Medical Research /ID# 212841	Ponce
Puerto Rico	Mindful Medical Research /ID# 212496	San Juan
United States	Atlanta Women's Research Institute /ID# 217745	Atlanta	Georgia
United States	Georgia Research for Women /ID# 211321	Atlanta	Georgia
United States	Medisense Inc /ID# 217750	Atlanta	Georgia
United States	Women's Health of Augusta /ID# 214995	Augusta	Georgia
United States	Johns Hopkins University /ID# 211135	Baltimore	Maryland
United States	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	Clinical Trials of SC /ID# 210204	Charleston	South Carolina
United States	Chattanooga Medical Research /ID# 215294	Chattanooga	Tennessee
United States	Midtown OBGYN North /ID# 209391	Columbus	Georgia
United States	Clinical Trials Management, LLC - Covington /ID# 215020	Covington	Louisiana
United States	NECCR Fall River LLC /ID# 215009	Fall River	Massachusetts
United States	Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764	Fort Myers	Florida
United States	Signature Gyn Services /ID# 213883	Fort Worth	Texas
United States	FMC Science, LLC - OB/GYN - Georgetown /ID# 211164	Georgetown	Texas
United States	Advances in Health, Inc. /ID# 215847	Houston	Texas
United States	University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193	Houston	Texas
United States	Caceres Specialized Gynecology /ID# 214956	Kissimmee	Florida
United States	Grossmont Ctr Clin Research /ID# 217690	La Mesa	California
United States	Excel Clinical Research /ID# 215936	Las Vegas	Nevada
United States	WR-Medical Research Center of Memphis LLC /ID# 213756	Memphis	Tennessee
United States	Southern Clinical Research A /ID# 213732	Metairie	Louisiana
United States	Genoma Research Group, Inc /ID# 213771	Miami	Florida
United States	LCC Medical Research Institute /ID# 213765	Miami	Florida
United States	Access Clinical Trials, Inc. /ID# 215357	Nashville	Tennessee
United States	Manhattan Medical Research /ID# 213753	New York	New York
United States	Affinity Clinical Research /ID# 215252	Oak Brook	Illinois
United States	A Premier Medical Research of FL /ID# 214947	Orange City	Florida
United States	Clinical Research of Philadelphia, LLC /ID# 213741	Philadelphia	Pennsylvania
United States	Legacy Medical Group-Gynecologic Oncology /ID# 211016	Portland	Oregon
United States	M3 Wake Research Inc. /ID# 215166	Raleigh	North Carolina
United States	Clinical Trials of Texas, Inc /ID# 213768	San Antonio	Texas
United States	Discovery Clinical Trials-San Antonio /ID# 214996	San Antonio	Texas
United States	Women's Health Care Research Corp /ID# 211472	San Diego	California
United States	Unity Health- Searcy Medical Center /ID# 210905	Searcy	Arkansas
United States	Seattle Clinical Research Center /ID# 210853	Seattle	Washington
United States	Journey Medical Research Institute - Snellville /ID# 217309	Snellville	Georgia
United States	North Spokane Women's Health /ID# 209889	Spokane	Washington
United States	Houston Ctr for Clin Research /ID# 215138	Sugar Land	Texas
United States	Storks Research, LLC /ID# 211146	Sugar Land	Texas
United States	GCP Clinical Research, LLC /ID# 218742	Tampa	Florida
United States	Comprehensive Clinical Trials LLC /ID# 217177	West Palm Beach	Florida
United States	Reading Hospital Clinical Trials Office /ID# 213763	West Reading	Pennsylvania
United States	Upstate Clinical Research Associates /ID# 215156	Williamsville	New York
United States	Carolina Medical Trials - Winston-Salem /ID# 215027	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From Month 0 (Baseline) to Final Month (up to Month 6)

External Links

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