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



Status:Completed
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 51
Updated:2/13/2019
Start Date:December 22, 2015
End Date:December 12, 2018

Use our guide to learn which trials are right for you!

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

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.


Inclusion Criteria:

- Subject is a premenopausal female at the time of Screening.

- Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (TAU,
TVU).

- Subject has HMB associated with uterine fibroids as evidenced by MBL > 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 SIS 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.
We found this trial at
92
sites
Clearwater, Florida 33759
?
mi
from 02139
Clearwater, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
1959
mi
from 02139
Albuquerque, NM
Click here to add this to my saved trials
Alpharetta, Georgia 30005
?
mi
from 02139
Alpharetta, GA
Click here to add this to my saved trials
Alpharetta, Georgia 30005
?
mi
from 02139
Alpharetta, GA
Click here to add this to my saved trials
750 Hammond Drive Northeast
Atlanta, Georgia 30342
925
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
?
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
1113 Garredd Boulevard
Augusta, Georgia 30909
856
mi
from 02139
Augusta, GA
Click here to add this to my saved trials
8607 East US Highway 36
Avon, Indiana 46123
814
mi
from 02139
Avon, IN
Click here to add this to my saved trials
200 S Wenona St # 170
Bay City, Michigan 48706
652
mi
from 02139
Bay City, MI
Click here to add this to my saved trials
Birmingham, Alabama 35235
?
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
10798 West Overland Road
Boise, Idaho 83709
2258
mi
from 02139
Boise, ID
Click here to add this to my saved trials
2609 Woolbright Road
Boynton Beach, Florida 33436
1207
mi
from 02139
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from 02139
Brandon, FL
Click here to add this to my saved trials
825 Old Lancaster Road
Bryn Mawr, Pennsylvania 19010
272
mi
from 02139
Bryn Mawr, PA
Click here to add this to my saved trials
2125 South Neil Street
Champaign, Illinois 61820
903
mi
from 02139
Champaign, IL
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from 02139
Charleston, SC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from 02139
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60640
847
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45267
?
mi
from 02139
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from 02139
Cleveland, OH
Click here to add this to my saved trials
6160 Tutt Boulevard
Colorado Springs, Colorado 80923
1766
mi
from 02139
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, South Carolina 29201
790
mi
from 02139
Columbia, SC
Click here to add this to my saved trials
5888 Cleveland Avenue
Columbus, Ohio 43231
634
mi
from 02139
Columbus, OH
Click here to add this to my saved trials
3545 Howard Way
Costa Mesa, California 92626
2583
mi
from 02139
Costa Mesa, CA
Click here to add this to my saved trials
Covington, Louisiana 70433
?
mi
from 02139
Covington, LA
Click here to add this to my saved trials
1547
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
704
mi
from 02139
Dayton, OH
Click here to add this to my saved trials
?
mi
from 02139
Doral, FL
Click here to add this to my saved trials
Durham, North Carolina 27713
?
mi
from 02139
Durham, NC
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from 02139
Fall River, MA
Click here to add this to my saved trials
13670 Metropolis Avenue
Fort Myers, Florida 33912
1250
mi
from 02139
Fort Myers, FL
Click here to add this to my saved trials
Frederick, Maryland 21708
?
mi
from 02139
Frederick, MD
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
739
mi
from 02139
Grand Rapids, MI
Click here to add this to my saved trials
?
mi
from 02139
Greensboro, NC
Click here to add this to my saved trials
Greenwood Village, Colorado 80111
?
mi
from 02139
Greenwood Village, CO
Click here to add this to my saved trials
Hawaiian Gardens, California 90716
2586
mi
from 02139
Hawaiian Gardens, CA
Click here to add this to my saved trials
500 University Drive
Hershey, Pennsylvania 17033
323
mi
from 02139
Hershey, PA
Click here to add this to my saved trials
7515 Main Street
Houston, Texas 77030
1606
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Kansas City, Kansas 66218
?
mi
from 02139
Kansas City, KS
Click here to add this to my saved trials
Kenneth City, Florida 33709
?
mi
from 02139
Kenneth City, FL
Click here to add this to my saved trials
La Mesa, California 91942
?
mi
from 02139
La Mesa, CA
Click here to add this to my saved trials
4671 South Congress Avenue
Lake Worth, Florida 33461
1201
mi
from 02139
Lake Worth, FL
Click here to add this to my saved trials
8285 West Arby Avenue
Las Vegas, Nevada 89113
2376
mi
from 02139
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89128
?
mi
from 02139
Las Vegas, NV
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
?
mi
from 02139
Lawrenceville, NJ
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from 02139
Long Beach, CA
Click here to add this to my saved trials
2010 Wilshire Boulevard
Los Angeles, California 90057
2589
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 02139
Margate, FL
Click here to add this to my saved trials
?
mi
from 02139
Memphis, TN
Click here to add this to my saved trials
1259
mi
from 02139
Miami, FL
Click here to add this to my saved trials
?
mi
from 02139
Miami, FL
Click here to add this to my saved trials
?
mi
from 02139
Miami, FL
Click here to add this to my saved trials
12741 Miramar Parkway
Miramar, Florida 33027
1246
mi
from 02139
Miramar, FL
Click here to add this to my saved trials
1707 Center Street
Mobile, Alabama 36604
1235
mi
from 02139
Mobile, AL
Click here to add this to my saved trials
2201 Murphy Avenue
Nashville, Tennessee 37203
941
mi
from 02139
Nashville, TN
Click here to add this to my saved trials
2700 Napoleon Avenue
New Orleans, Louisiana 70115
1358
mi
from 02139
New Orleans, LA
Click here to add this to my saved trials
7114 Congress Street
New Port Richey, Florida 34653
1171
mi
from 02139
New Port Richey, FL
Click here to add this to my saved trials
New York, New York 10016
?
mi
from 02139
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92663
2586
mi
from 02139
Newport Beach, CA
Click here to add this to my saved trials
825 Fairfax Avenue
Norfolk, Virginia 23507
470
mi
from 02139
Norfolk, VA
Click here to add this to my saved trials
North Chesterfield, Virginia 23235
?
mi
from 02139
North Chesterfield, VA
Click here to add this to my saved trials
Oak Brook, Illinois 60523
?
mi
from 02139
Oak Brook, IL
Click here to add this to my saved trials
114 West Underwood Street
Orlando, Florida 32806
1115
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
?
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
?
mi
from 02139
Ottawa,
Click here to add this to my saved trials
1200 Breckenridge Street
Owensboro, Kentucky 42303
901
mi
from 02139
Owensboro, KY
Click here to add this to my saved trials
Panama City, Florida 32045
?
mi
from 02139
Panama City, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from 02139
Philadelphia, PA
Click here to add this to my saved trials
3401 North Broad Street
Philadelphia, Pennsylvania 19140
266
mi
from 02139
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15206
?
mi
from 02139
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from 02139
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from 02139
Raleigh, NC
Click here to add this to my saved trials
6767 Forest Hill Avenue
Richmond, Virginia 23225
475
mi
from 02139
Richmond, VA
Click here to add this to my saved trials
4118 Pond Hill Road
San Antonio, Texas 78231
1759
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
?
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
7 Oglethorpe Professional Boulevard
Savannah, Georgia 31406
901
mi
from 02139
Savannah, GA
Click here to add this to my saved trials
3216 Northeast 45th Place
Seattle, Washington 98105
2480
mi
from 02139
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71118
?
mi
from 02139
Shreveport, LA
Click here to add this to my saved trials
?
mi
from 02139
Southfield, MI
Click here to add this to my saved trials
324 South Sherman Street
Spokane, Washington 99202
2256
mi
from 02139
Spokane, WA
Click here to add this to my saved trials
?
mi
from 02139
Sugar Land, TX
Click here to add this to my saved trials
3000 Arlington Avenue
Toledo, Ohio 43614
643
mi
from 02139
Toledo, OH
Click here to add this to my saved trials
Vienna, Virginia 22182
401
mi
from 02139
Vienna, VA
Click here to add this to my saved trials
110 Irving Street Northwest
Washington, District of Columbia 20010
390
mi
from 02139
Washington,
Click here to add this to my saved trials
Washington, District of Columbia 20036
392
mi
from 02139
Washington,
Click here to add this to my saved trials
?
mi
from 02139
Webster, TX
Click here to add this to my saved trials
603 Village Boulevard
West Palm Beach, Florida 33409
1194
mi
from 02139
West Palm Beach, FL
Click here to add this to my saved trials
Westminster, California 92683
?
mi
from 02139
Westminster, CA
Click here to add this to my saved trials
9300 East 29th Street North
Wichita, Kansas 67226
1412
mi
from 02139
Wichita, KS
Click here to add this to my saved trials
1907 Tradd Court
Wilmington, North Carolina 28401
673
mi
from 02139
Wilmington, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from 02139
Winston-Salem, NC
Click here to add this to my saved trials