Phase
Condition
Hemorrhage
Uterine Fibroids
Sarcoma (Pediatric)
Treatment
N/AClinical Study ID
Ages 18-51 Female
Study Summary
Eligibility Criteria
Inclusion
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 bymenstrual blood loss > 80 mL during each of two screening menses as measured by thealkaline hematin method.
Subject has negative urine and/or serum pregnancy test in Screening and just prior tofirst dose.
Subject has an adequate endometrial biopsy performed during Screening, the results ofwhich show no clinically significant endometrial pathology.
Exclusion
Exclusion Criteria:
Subject has screening pelvic ultrasound or saline infusion sonohysterography resultsthat 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, orurinalysis.
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 anytime (e.g., schizophrenia, bipolar disorder).
Subject is using any systemic corticosteroids for over 14 days within 3 months priorto Screening or is likely to require treatment with systemic corticosteroids duringthe course of the study. Over the counter and prescription topical, inhaled,intranasal or injectable (for occasional use) corticosteroids are allowed.
Study Design
Connect with a study center
IWK Health Center /ID# 149066
Halifax, Nova Scotia B3K 6R8
CanadaSite Not Available
The Ottawa Hospital /ID# 148695
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Ponce Medical School Foundation Inc. /ID# 151735
Ponce, 00717
Puerto RicoSite Not Available
University of Puerto Rico, School of Medicine /ID# 139848
Rio Piedas, 00935
Puerto RicoSite Not Available
University of Puerto Rico, School of Medicine /ID# 139848
Rio Piedras, 00935
Puerto RicoSite Not Available
Rodriguez-Ginorio, San Juan /ID# 139847
San Juan, 00917
Puerto RicoSite Not Available
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848
San Juan, 00935
Puerto RicoSite Not Available
Summers, Birmingham, AL /ID# 139684
Birmingham, Alabama 35235
United StatesSite Not Available
University of South Alabama /ID# 148763
Mobile, Alabama 36604-3302
United StatesSite Not Available
Mesa Obstetricians and Gynecologists /ID# 147115
Mesa, Arizona 85209
United StatesSite Not Available
MomDoc Womens Health Research /ID# 151656
Phoenix, Arizona 85251
United StatesSite Not Available
Reliance Institute of Clinical Research /ID# 139729
Chino, California 91710
United StatesSite Not Available
WCCT Global, LLC /ID# 145666
Costa Mesa, California 92626
United StatesSite Not Available
American Clinical Trials /ID# 147374
Hawaiian Gardens, California 90716
United StatesSite Not Available
Grossmont Ctr Clin Research /ID# 144011
La Mesa, California 91942
United StatesSite Not Available
Long Beach Clinical Trial Serv /ID# 152424
Long Beach, California 90806
United StatesSite Not Available
National Research Institute /ID# 151629
Los Angeles, California 90057
United StatesSite Not Available
University of California, Los Angeles /ID# 144107
Los Angeles, California 90095
United StatesSite Not Available
Beach OBGYN Medical Group /ID# 151414
Newport Beach, California 92663-3657
United StatesSite Not Available
University of California, Los Angeles /ID# 144107
Santa Monica, California 90404
United StatesSite Not Available
Harbor-UCLA Medical Center And Labiomed Research Institute /ID# 144107
Torrance, California 90502
United StatesSite Not Available
Advanced RX Clinical Research /ID# 149168
Westminster, California 92683-4567
United StatesSite Not Available
Bluebird Clinical Trials, LLC /ID# 144843
Colorado Springs, Colorado 80923
United StatesSite Not Available
Advanced Women's Health Instit /ID# 144108
Denver, Colorado 80246
United StatesSite Not Available
Advanced Women's Health Institution /ID# 144108
Greenwood Village, Colorado 80111
United StatesSite Not Available
James A. Simon, MD, PC /ID# 139675
Washington, District of Columbia 20036
United StatesSite Not Available
Medstar Health Research Institute /ID# 145933
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center /ID# 145933
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Helix Biomedics, LLC /ID# 147114
Boynton Beach, Florida 33436-6634
United StatesSite Not Available
Brandon Premier Health Care, PA /ID# 153130
Brandon, Florida 33510-3107
United StatesSite Not Available
Florida Clin Res Group /ID# 139811
Ckearwater, Florida 33759
United StatesSite Not Available
Florida Clin Res Group /ID# 139811
Clearwater, Florida 33759
United StatesSite Not Available
Omega Research Consultants, LLC /ID# 139648
Debary, Florida 32713
United StatesSite Not Available
Universal Clinical Research A /ID# 139742
Doral, Florida 33166
United StatesSite Not Available
Clinical Physiology Associates /ID# 139736
Fort Myers, Florida 33912
United StatesSite Not Available
Meridien Research /ID# 139663
Kenneth City, Florida 33709-3113
United StatesSite Not Available
Altus Research, Inc /ID# 139662
Lake Worth, Florida 33461
United StatesSite Not Available
South Florida Wellness & Clinic /ID# 143558
Margate, Florida 33063
United StatesSite Not Available
Healthcare Clinical Data, Inc /ID# 139650
Miami, Florida 33161
United StatesSite Not Available
LCC Medical Research Institute /ID# 143551
Miami, Florida 33126
United StatesSite Not Available
Ocean Blue Med Research Ctr /ID# 139826
Miami, Florida 33166
United StatesSite Not Available
Ocean Blue Medical Research Center, Inc. /ID# 139826
Miami Springs, Florida 33166
United StatesSite Not Available
Salom Tangir, LLC /ID# 151732
Miramar, Florida 33027
United StatesSite Not Available
Advanced Research Institute /ID# 143554
New Port Richey, Florida 34653
United StatesSite Not Available
Healthcare Clinical Data, Inc. /ID# 139650
North Miami, Florida 33161
United StatesSite Not Available
Clinical Associates of Orlando /ID# 148123
Orlando, Florida 32806
United StatesSite Not Available
Omega Research Consultants /ID# 139648
Orlando, Florida 32810
United StatesSite Not Available
Unified Womens Clin Research /ID# 145169
Panama City, Florida 32045
United StatesSite Not Available
Meridien Research
Saint Petersburg, Florida 33709
United StatesSite Not Available
Meridien Research /ID# 139663
St. Petersburg, Florida 33709
United StatesSite Not Available
Comprehensive Clinical Trials /ID# 139644
West Palm Beach, Florida 33409
United StatesSite Not Available
Atlanta Medical Research Insti /ID# 147117
Alpharetta, Georgia 30005-4419
United StatesSite Not Available
Paramount Research Solutions /ID# 139645
Alpharetta, Georgia 30005
United StatesSite Not Available
Agile Clinical Research Trials /ID# 143563
Atlanta, Georgia 30328
United StatesSite Not Available
Perimeter Inst Clinical Resear /ID# 148298
Atlanta, Georgia 30338
United StatesSite Not Available
Masters of Clinical Research, Inc. /ID# 139658
Augusta, Georgia 30909
United StatesSite Not Available
GYN-CARE/ Paramount Research Solutions /ID# 139645
College Park, Georgia 30349
United StatesSite Not Available
Fellows Research Alliance, Inc /ID# 139655
Savannah, Georgia 31406
United StatesSite Not Available
Boise Family Medical Center /ID# 139844
Boise, Idaho 83709
United StatesSite Not Available
Women's Health Practice, LLC /ID# 143569
Champaign, Illinois 61820
United StatesSite Not Available
Great Lakes Clinical Trials /ID# 148135
Chicago, Illinois 60640
United StatesSite Not Available
Affinity Clinical Research /ID# 150980
Oak Brook, Illinois 60523
United StatesSite Not Available
American Health Network of IN /ID# 139822
Avon, Indiana 46123
United StatesSite Not Available
GTC Research /ID# 141854
Kansas City, Kansas 66218
United StatesSite Not Available
GTC Research /ID# 141854
Shawnee, Kansas 66218
United StatesSite Not Available
GTC Research /ID# 141854
Shawnee Mission, Kansas 66218
United StatesSite Not Available
Cypress Medical Research Ctr /ID# 147116
Wichita, Kansas 67226
United StatesSite Not Available
Research Integrity, LLC /ID# 139727
Owensboro, Kentucky 42303-1089
United StatesSite Not Available
Clinical Trials Management, LLC - Covington /ID# 139651
Covington, Louisiana 70433
United StatesSite Not Available
Clinical Trials Management,LLC
Metairie, Louisiana 70006
United StatesSite Not Available
Ochsner Baptist Medical Center /ID# 139740
New Orleans, Louisiana 70115
United StatesSite Not Available
Omni Fertility and Laser Insti /ID# 139836
Shreveport, Louisiana 71118
United StatesSite Not Available
Mercy Medical Center /ID# 152035
Baltimore, Maryland 21202
United StatesSite Not Available
Capital Women's Care /ID# 144109
Frederick, Maryland 21708
United StatesSite Not Available
Genesis Clinical Research - Fall River /ID# 148449
Fall River, Massachusetts 02723
United StatesSite Not Available
Great Lakes Research Group,Inc /ID# 139659
Bay City, Michigan 48706
United StatesSite Not Available
Grand Rapids Womens Health /ID# 139705
Grand Rapids, Michigan 49503
United StatesSite Not Available
Wayne State University Physician Group - Southfield /ID# 139802
Southfield, Michigan 48034
United StatesSite Not Available
Saint Louis University /ID# 145936
St.Louis, Missouri 63117
United StatesSite Not Available
Mabey, Las Vegas, NV /ID# 148138
Las Vegas, Nevada 89128
United StatesSite Not Available
Office of Edmond E. Pack, MD /ID# 139792
Las Vegas, Nevada 89113
United StatesSite Not Available
Lawrence OB/GYN /ID# 143567
Lawrenceville, New Jersey 08648
United StatesSite Not Available
Bosque Women's Care /ID# 145934
Albuquerque, New Mexico 87109
United StatesSite Not Available
Manhattan Medical Research /ID# 144471
New York, New York 10016-6023
United StatesSite Not Available
Cwrwc /Id# 139664
Durham, North Carolina 27713
United StatesSite Not Available
Unified Women's Clinical Research-Greensboro /ID# 139829
Greensboro, North Carolina 27408
United StatesSite Not Available
Unified Women's Clinical Resea /ID# 139774
Raleigh, North Carolina 27607
United StatesSite Not Available
PMG Research of Wilmington LLC /ID# 152563
Wilmington, North Carolina 28401
United StatesSite Not Available
Unified Women's Clinical Resea /ID# 144721
Winston-Salem, North Carolina 27103
United StatesSite Not Available
University of Cincinnati /ID# 139820
Cincinnati, Ohio 45267-0585
United StatesSite Not Available
Univ Hosp Cleveland /ID# 139741
Cleveland, Ohio 44106
United StatesSite Not Available
Complete Healthcare for Women /ID# 139673
Columbus, Ohio 43231
United StatesSite Not Available
Miami Valley Hospital /ID# 144430
Dayton, Ohio 45409
United StatesSite Not Available
University of Toledo /ID# 139787
Toledo, Ohio 43614
United StatesSite Not Available
OU Physicians Urology /ID# 148690
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Legacy Medical Group-Portland /ID# 148807
Portland, Oregon 97210
United StatesSite Not Available
Main Line Fertility Center /ID# 150295
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available
Penn State University and Milton S. Hershey Medical Center /ID# 139733
Hershey, Pennsylvania 17033
United StatesSite Not Available
Temple University Hospital /ID# 151429
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Thomas Jefferson University /ID# 139812
Philadelphia, Pennsylvania 19107-4414
United StatesSite Not Available
Clinical Trials Research Svcs /ID# 139707
Pittsburgh, Pennsylvania 15206
United StatesSite Not Available
Medical University of South Carolina /ID# 148754
Charleston, South Carolina 29425
United StatesSite Not Available
Vista Clinical Research /ID# 139797
Columbia, South Carolina 29201
United StatesSite Not Available
WR-ClinSearch /ID# 143538
Chattanooga, Tennessee 37421-1605
United StatesSite Not Available
Chattanooga GYN Oncology LLC /ID# 143538
Hixon, Tennessee 37343
United StatesSite Not Available
The Jackson Clinic, PA /ID# 151188
Jackson, Tennessee 38305
United StatesSite Not Available
Research Memphis Associates, LLC /ID# 139674
Memphis, Tennessee 38119-3895
United StatesSite Not Available
Access Clinical Trials, Inc. /ID# 139730
Nashville, Tennessee 37203
United StatesSite Not Available
Tekton Research, Inc. /ID# 143984
Austin, Texas 78739
United StatesSite Not Available
UT Southwestern Medical Center /ID# 143537
Dallas, Texas 75390-7208
United StatesSite Not Available
Advances in Health, Inc. /ID# 139672
Houston, Texas 77030
United StatesSite Not Available
Discovery Clinical Trials-San Antonio /ID# 139776
San Antonio, Texas 78258
United StatesSite Not Available
Victorium Clinical Research /ID# 149630
San Antonio, Texas 78230
United StatesSite Not Available
Houston Ctr for Clin Research /ID# 149149
Sugar Land, Texas 77479
United StatesSite Not Available
Houston Center for Clinical Research /ID# 149149
Sugarland, Texas 77479
United StatesSite Not Available
Baylor Scott & White Health /ID# 143982
Temple, Texas 76508
United StatesSite Not Available
Center of Reproductive Medicin /ID# 139813
Webster, Texas 77598
United StatesSite Not Available
Eastern Virginia Med School /ID# 139647
Norfolk, Virginia 23507-1627
United StatesSite Not Available
Clinical Research Partners, LL /ID# 143999
North Chesterfield, Virginia 23235-4722
United StatesSite Not Available
Clinical Trials Virginia, Inc. /ID# 139801
Richmond, Virginia 23225
United StatesSite Not Available
Emerson Clinical Research /ID# 147373
Vienna, Virginia 22182
United StatesSite Not Available
Zain Research /ID# 139744
Richland, Washington 99352
United StatesSite Not Available
Seattle Women's Health, Research, Gynecology /ID# 139768
Seattle, Washington 98105
United StatesSite Not Available
Premier Clinical Research /ID# 148145
Spokane, Washington 99202
United StatesSite Not Available
Froedtert and Medical College /ID# 143566
Milwaukee, Wisconsin 53226-3522
United StatesSite Not Available
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