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

Uterine Fibroids Clinical Trial

Official title:

A Phase 3 Study to Evaluate the 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654054
• Other study ID #: M12-815
• Status: Completed
• Phase: Phase 3
• Start date: December 22, 2015
• Est. completion date: December 12, 2018

Study information

• Verified date: June 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: December 12, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Intervention

Drug:
• Elagolix
Film-coated tablets
• Placebo for Estradiol/Norethindrone Acetate
Placebo capsules
• Estradiol/Norethindrone Acetate
Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
• Placebo for Elagolix
Film-coated placebo tablets

Locations

Country	Name	City	State
Canada	IWK Health Center /ID# 149066	Halifax	Nova Scotia
Canada	The Ottawa Hospital /ID# 148695	Ottawa	Ontario
Puerto Rico	Rodriguez-Ginorio, San Juan /ID# 139847	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848	San Juan
United States	Bosque Women's Care /ID# 145934	Albuquerque	New Mexico
United States	Atlanta Medical Research Insti /ID# 147117	Alpharetta	Georgia
United States	Paramount Research Solutions /ID# 139645	Alpharetta	Georgia
United States	Agile Clinical Research Trials /ID# 143563	Atlanta	Georgia
United States	Perimeter Inst Clinical Resear /ID# 148298	Atlanta	Georgia
United States	Masters of Clinical Research, Inc. /ID# 139658	Augusta	Georgia
United States	American Health Network of IN /ID# 139822	Avon	Indiana
United States	Great Lakes Research Group,Inc /ID# 139659	Bay City	Michigan
United States	Summers, Birmingham, AL /ID# 139684	Birmingham	Alabama
United States	Boise Family Medical Center /ID# 139844	Boise	Idaho
United States	Helix Biomedics, LLC /ID# 147114	Boynton Beach	Florida
United States	Brandon Premier Health Care, PA /ID# 153130	Brandon	Florida
United States	Main Line Fertility Center /ID# 150295	Bryn Mawr	Pennsylvania
United States	Women's Health Practice, LLC /ID# 143569	Champaign	Illinois
United States	Medical University of South Carolina /ID# 148754	Charleston	South Carolina
United States	WR-ClinSearch /ID# 143538	Chattanooga	Tennessee
United States	Great Lakes Clinical Trials /ID# 148135	Chicago	Illinois
United States	University of Cincinnati /ID# 139820	Cincinnati	Ohio
United States	Florida Clin Res Group /ID# 139811	Ckearwater	Florida
United States	Univ Hosp Cleveland /ID# 139741	Cleveland	Ohio
United States	Bluebird Clinical Trials, LLC /ID# 144843	Colorado Springs	Colorado
United States	Vista Clinical Research /ID# 139797	Columbia	South Carolina
United States	Complete Healthcare for Women /ID# 139673	Columbus	Ohio
United States	WCCT Global, LLC /ID# 145666	Costa Mesa	California
United States	Clinical Trials Management, LLC - Covington /ID# 139651	Covington	Louisiana
United States	UT Southwestern Medical Center /ID# 143537	Dallas	Texas
United States	Miami Valley Hospital /ID# 144430	Dayton	Ohio
United States	Universal Clinical Research A /ID# 139742	Doral	Florida
United States	Cwrwc /Id# 139664	Durham	North Carolina
United States	Genesis Clinical Research - Fall River /ID# 148449	Fall River	Massachusetts
United States	Clinical Physiology Associates /ID# 139736	Fort Myers	Florida
United States	Capital Women's Care /ID# 144109	Frederick	Maryland
United States	Grand Rapids Womens Health /ID# 139705	Grand Rapids	Michigan
United States	Unified Women's Clinical Research-Greensboro /ID# 139829	Greensboro	North Carolina
United States	Advanced Women's Health Institution /ID# 144108	Greenwood Village	Colorado
United States	American Clinical Trials /ID# 147374	Hawaiian Gardens	California
United States	Penn State University and Milton S. Hershey Medical Center /ID# 139733	Hershey	Pennsylvania
United States	Advances in Health, Inc. /ID# 139672	Houston	Texas
United States	GTC Research /ID# 141854	Kansas City	Kansas
United States	Meridien Research /ID# 139663	Kenneth City	Florida
United States	Grossmont Ctr Clin Research /ID# 144011	La Mesa	California
United States	Altus Research, Inc /ID# 139662	Lake Worth	Florida
United States	Mabey, Las Vegas, NV /ID# 148138	Las Vegas	Nevada
United States	Office of Edmond E. Pack, MD /ID# 139792	Las Vegas	Nevada
United States	Lawrence OB/GYN /ID# 143567	Lawrenceville	New Jersey
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	South Florida Wellness & Clinic /ID# 143558	Margate	Florida
United States	Research Memphis Associates, LLC /ID# 139674	Memphis	Tennessee
United States	Healthcare Clinical Data, Inc /ID# 139650	Miami	Florida
United States	LCC Medical Research Institute /ID# 143551	Miami	Florida
United States	Ocean Blue Med Research Ctr /ID# 139826	Miami	Florida
United States	Froedtert and Medical College /ID# 143566	Milwaukee	Wisconsin
United States	Salom Tangir, LLC /ID# 151732	Miramar	Florida
United States	University of South Alabama /ID# 148763	Mobile	Alabama
United States	Access Clinical Trials, Inc. /ID# 139730	Nashville	Tennessee
United States	Ochsner Baptist Medical Center /ID# 139740	New Orleans	Louisiana
United States	Advanced Research Institute /ID# 143554	New Port Richey	Florida
United States	Manhattan Medical Research /ID# 144471	New York	New York
United States	Beach OBGYN Medical Group /ID# 151414	Newport Beach	California
United States	Eastern Virginia Med School /ID# 139647	Norfolk	Virginia
United States	Clinical Research Partners, LL /ID# 143999	North Chesterfield	Virginia
United States	Affinity Clinical Research /ID# 150980	Oak Brook	Illinois
United States	Clinical Associates of Orlando /ID# 148123	Orlando	Florida
United States	Omega Research Consultants /ID# 139648	Orlando	Florida
United States	Research Integrity, LLC /ID# 139727	Owensboro	Kentucky
United States	Unified Womens Clin Research /ID# 145169	Panama City	Florida
United States	Temple University Hospital /ID# 151429	Philadelphia	Pennsylvania
United States	Thomas Jefferson University /ID# 139812	Philadelphia	Pennsylvania
United States	Clinical Trials Research Svcs /ID# 139707	Pittsburgh	Pennsylvania
United States	Legacy Medical Group-Portland /ID# 148807	Portland	Oregon
United States	Unified Women's Clinical Resea /ID# 139774	Raleigh	North Carolina
United States	Clinical Trials Virginia, Inc. /ID# 139801	Richmond	Virginia
United States	Discovery Clinical Trials-San Antonio /ID# 139776	San Antonio	Texas
United States	Victorium Clinical Research /ID# 149630	San Antonio	Texas
United States	Fellows Research Alliance, Inc /ID# 139655	Savannah	Georgia
United States	Seattle Women's Health, Research, Gynecology /ID# 139768	Seattle	Washington
United States	Omni Fertility and Laser Insti /ID# 139836	Shreveport	Louisiana
United States	Wayne State University Physician Group - Southfield /ID# 139802	Southfield	Michigan
United States	Premier Clinical Research /ID# 148145	Spokane	Washington
United States	Houston Ctr for Clin Research /ID# 149149	Sugar Land	Texas
United States	University of Toledo /ID# 139787	Toledo	Ohio
United States	Emerson Clinical Research /ID# 147373	Vienna	Virginia
United States	James A. Simon, MD, PC /ID# 139675	Washington	District of Columbia
United States	Medstar Health Research Institute /ID# 145933	Washington	District of Columbia
United States	Center of Reproductive Medicin /ID# 139813	Webster	Texas
United States	Comprehensive Clinical Trials /ID# 139644	West Palm Beach	Florida
United States	Advanced RX Clinical Research /ID# 149168	Westminster	California
United States	Cypress Medical Research Ctr /ID# 147116	Wichita	Kansas
United States	PMG Research of Wilmington LLC /ID# 152563	Wilmington	North Carolina
United States	Unified Women's Clinical Resea /ID# 144721	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Meeting the Criteria for Responder	Percentage of responders, defined as participants who met the following conditions: Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period [last treatment visit date] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and; = 50% reduction in MBL volume from Baseline to the Final Month.; Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Secondary	Change From Baseline in MBL Volume to the Final Month	Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.; The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.	Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Secondary	Percentage of Participants With Suppression of Bleeding at the Final Month	Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.; The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Secondary	Change From Baseline in MBL Volume to Month 6		Month 0 (Baseline), Month 6
Secondary	Change From Baseline in MBL Volume to Month 3		Month 0 (Baseline), Month 3
Secondary	Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6		Month 0 (Baseline), Month 6
Secondary	Change From Baseline in MBL Volume to Month 1		Month 0 (Baseline), Month 1