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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925494
• Other study ID #: M12-816
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2016
• Est. completion date: March 22, 2019

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: March 22, 2019
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Estradiol/Norethindrone Acetate
capsules
• Elagolix
film-coated tablets

Locations

Country	Name	City	State
Canada	Victory Reproductive Care /ID# 153299	Windsor	Ontario
Puerto Rico	Rodriguez-Ginorio, San Juan /ID# 153328	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329	San Juan
United States	Bosque Women's Care /ID# 153223	Albuquerque	New Mexico
United States	Atlanta Medical Research Insti /ID# 153298	Alpharetta	Georgia
United States	Paramount Research Solutions /ID# 153424	Alpharetta	Georgia
United States	Paramount Research Solutions /ID# 160974	Alpharetta	Georgia
United States	Atlanta Women's Research Inst /ID# 153212	Atlanta	Georgia
United States	Mount Vernon Clinical Res, LLC /ID# 153403	Atlanta	Georgia
United States	Masters of Clinical Research, Inc. /ID# 153295	Augusta	Georgia
United States	Lotus Gynecology /ID# 153476	Austin	Texas
United States	Baltimore Suburban Health /ID# 168386	Baltimore	Maryland
United States	Great Lakes Research Group,Inc /ID# 153302	Bay City	Michigan
United States	Clinical Inquest Center Ltd /ID# 153436	Beavercreek	Ohio
United States	Alabama Clinical Therapeutics, LLC /ID# 153217	Birmingham	Alabama
United States	Alabama Clinical Therapeutics, LLC /ID# 153336	Birmingham	Alabama
United States	Helix Biomedics, LLC /ID# 153440	Boynton Beach	Florida
United States	Brandon Premier Health Care, PA /ID# 165791	Brandon	Florida
United States	SUNY Downstate Medical Center /ID# 153344	Brooklyn	New York
United States	Main Line Fertility Center /ID# 153410	Bryn Mawr	Pennsylvania
United States	Core Healthcare Group /ID# 153282	Cerritos	California
United States	Medical University of South Carolina /ID# 153325	Charleston	South Carolina
United States	Chattanooga Medical Research /ID# 153405	Chattanooga	Tennessee
United States	WR-ClinSearch /ID# 153404	Chattanooga	Tennessee
United States	CTI Clinical Research Center /ID# 153201	Cincinnati	Ohio
United States	Florida Fertility Institute /ID# 153308	Clearwater	Florida
United States	University Hospitals Cleveland /ID# 153450	Cleveland	Ohio
United States	Paramount Research Solutions /ID# 153351	College Park	Georgia
United States	Vista Clinical Research /ID# 153399	Columbia	South Carolina
United States	Clinical Trials Management, LLC - Covington /ID# 153211	Covington	Louisiana
United States	Clinical Trials Management, LLC - Covington /ID# 153439	Covington	Louisiana
United States	Texas Health Presbyterian Hosp /ID# 153339	Dallas	Texas
United States	UT Southwestern Medical Center /ID# 153400	Dallas	Texas
United States	Omega Research Consultants, LLC /ID# 153381	DeBary	Florida
United States	Choice Research, LLC /ID# 153492	Dothan	Alabama
United States	Cwrwc /Id# 153313	Durham	North Carolina
United States	Diagnamics Inc. /ID# 153347	Encinitas	California
United States	Brown, Pearson, Guepet Gynecology /ID# 153278	Fairhope	Alabama
United States	Genesis Clinical Research /ID# 153379	Fall River	Massachusetts
United States	NECCR Fall River LLC /ID# 153274	Fall River	Massachusetts
United States	KO Clinical Research, LLC /ID# 153198	Fort Lauderdale	Florida
United States	Clinical Physiology Assoc. /ID# 153444	Fort Myers	Florida
United States	Baylor Scott & White /ID# 153273	Fort Worth	Texas
United States	Willowbend Health and Wellness /ID# 153458	Frisco	Texas
United States	Unified Women's Clinical Research-Greensboro /ID# 153499	Greensboro	North Carolina
United States	Advanced Women's Health Institution /ID# 153401	Greenwood Village	Colorado
United States	Penn State University and Milton S. Hershey Medical Center /ID# 153443	Hershey	Pennsylvania
United States	Pinewest Ob-Gyn, Inc. /ID# 153197	High Point	North Carolina
United States	Advances in Health, Inc. /ID# 153414	Houston	Texas
United States	The Woman's Hospital of Texas /ID# 153270	Houston	Texas
United States	Solutions Through Adv Rch /ID# 153283	Jacksonville	Florida
United States	Meridien Research /ID# 153310	Kenneth City	Florida
United States	Grossmont Ctr Clin Research /ID# 153324	La Mesa	California
United States	Altus Research, Inc /ID# 153307	Lake Worth	Florida
United States	FMC Science /ID# 153289	Lampasas	Texas
United States	Accent Clinical Trials /ID# 153474	Las Vegas	Nevada
United States	Mabey, Las Vegas, NV /ID# 153314	Las Vegas	Nevada
United States	Office of Edmond E. Pack, MD /ID# 153411	Las Vegas	Nevada
United States	Lawrence OB/GYN /ID# 153218	Lawrenceville	New Jersey
United States	Bluegrass Clinical Research /ID# 153280	Louisville	Kentucky
United States	South Florida Wellness & Clinic /ID# 153420	Margate	Florida
United States	Research Memphis Associates, LLC /ID# 153322	Memphis	Tennessee
United States	Women's Health Trials /ID# 153426	Menphis	Tennessee
United States	Sonora Clinical Research /ID# 153231	Meridian	Idaho
United States	Mesa Obstetricians and Gynecol /ID# 153269	Mesa	Arizona
United States	Healthcare Clinical Data, Inc /ID# 153425	Miami	Florida
United States	Invictus Clinical Research Group,LLC /ID# 153196	Miami	Florida
United States	LCC Medical Research Institute /ID# 153296	Miami	Florida
United States	Ocean Blue Med Research Ctr /ID# 153225	Miami	Florida
United States	Precision Research Org, LLC /ID# 153276	Miami Lakes	Florida
United States	Mobile, Ob-Gyn, P.C. /ID# 153442	Mobile	Alabama
United States	University of South Alabama /ID# 153415	Mobile	Alabama
United States	Access Clinical Trials, Inc. /ID# 153441	Nashville	Tennessee
United States	Jersey Shore University Medical Center /ID# 153495	Neptune	New Jersey
United States	Eastern Carolina Women's Centr /ID# 153341	New Bern	North Carolina
United States	Ochsner Baptist Medical Center /ID# 153459	New Orleans	Louisiana
United States	Advanced Research Institute /ID# 153413	New Port Richey	Florida
United States	Suncoast Clinical Research /ID# 153206	New Port Richey	Florida
United States	Manhattan Medical Research /ID# 153386	New York	New York
United States	Weill Cornell Medicine /ID# 153275	New York	New York
United States	Eastern Virginia Med School /ID# 153380	Norfolk	Virginia
United States	Tidewater Physicians for Women /ID# 153432	Norfolk	Virginia
United States	Clinical Research Partners, LL /ID# 153412	North Chesterfield	Virginia
United States	Futura Research, Inc. /ID# 153345	Norwalk	California
United States	Affinity Clinical Research /ID# 153417	Oak Brook	Illinois
United States	Clinical Associates of Orlando /ID# 153427	Orlando	Florida
United States	Unified Womens Clin Research /ID# 153229	Panama City	Florida
United States	Clinical Research of Philadelphia, LLC /ID# 153279	Philadelphia	Pennsylvania
United States	Thomas Jefferson University /ID# 153319	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 153203	Philadelphia	Pennsylvania
United States	All Wmns HC of West Broward /ID# 153434	Plantation	Florida
United States	Legacy Medical Group-Portland /ID# 168286	Portland	Oregon
United States	Unified Women's Clinical Resea /ID# 153312	Raleigh	North Carolina
United States	Wake Research Associates, LLC /ID# 153402	Raleigh	North Carolina
United States	Clinical Research Partners, LLC /ID# 153343	Richmond	Virginia
United States	Clinical Trials Virginia, Inc. /ID# 153419	Richmond	Virginia
United States	Saginaw Valley Med Res Group /ID# 153498	Saginaw	Michigan
United States	Oncova Clinical Research, Inc. /ID# 153497	Saint Cloud	Florida
United States	Clinical Trials of Texas,Inc. /ID# 153209	San Antonio	Texas
United States	Discovery Clinical Trials-San Antonio /ID# 153315	San Antonio	Texas
United States	Farid Yasharpour MD Medical Co /ID# 153482	San Fernando	California
United States	Physician Care Clin. Res., LLC /ID# 153210	Sarasota	Florida
United States	Fellows Research Alliance, Inc /ID# 153227	Savannah	Georgia
United States	Seattle Women's Health, Research, Gynecology /ID# 153306	Seattle	Washington
United States	Virginia Mason Medical Center /ID# 153342	Seattle	Washington
United States	Omni Fertility and Laser Insti /ID# 153228	Shreveport	Louisiana
United States	Qps-Mra, Llc /Id# 153456	South Miami	Florida
United States	Wayne State University Physician Group - Southfield /ID# 153418	Southfield	Michigan
United States	Houston Ctr for Clin Research /ID# 153221	Sugar Land	Texas
United States	Atlanta Gynecology Research Institute /ID# 200074	Suwanee	Georgia
United States	Clinical Research Consultants of Atlanta /ID# 153285	Suwanee	Georgia
United States	University of South Florida /ID# 153271	Tampa	Florida
United States	University of Toledo /ID# 153409	Toledo	Ohio
United States	Emerson Clinical Research Inst /ID# 153416	Vienna	Virginia
United States	Emerson Clinical Research Inst /ID# 162755	Washington	District of Columbia
United States	James A. Simon, MD, PC /ID# 153323	Washington	District of Columbia
United States	Medstar Health Research Institute /ID# 153321	Washington	District of Columbia
United States	Center of Reproductive Medicin /ID# 153320	Webster	Texas
United States	Axcess Medical Research /ID# 153500	Wellington	Florida
United States	Virtus Research Consultant,LLC /ID# 153398	Wellington	Florida
United States	Comprehensive Clinical Trials /ID# 153350	West Palm Beach	Florida
United States	Reading Hosp Clncl Trials Ofc /ID# 153475	West Reading	Pennsylvania
United States	Comprehensive Womens Care /ID# 153396	Westerville	Ohio
United States	Unified Women's Clinical Resea /ID# 153297	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

Simon JA, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Dayspring T, Feinberg EC, Gillispie V, Hurtado S, Kim J, Liu R, Owens CD, Muneyyirci-Delale O, Wang A, Watts NB, Schlaff WD. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 2020 Jun;135(6):1313-1326. doi: 10.1097/AOG.0000000000003869. — View Citation

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 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.	From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Secondary	Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period	Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, 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.	Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Secondary	Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period	Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, 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.	Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through 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.	Final Month of Treatment Period (up through Month 6)
Secondary	Percentage of Participants With Baseline Hemoglobin Concentration = 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period		Month 6