Phase
Condition
Uterine Fibroids
Heavy Bleeding / Heavy Periods
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
Medicor Research Inc. /ID# 153406
Sudbury, Ontario P3A 1W8
CanadaSite Not Available
Victory Reproductive Care /ID# 150247
Windsor, Ontario N8W 5R7
CanadaSite Not Available
Site Reference ID/Investigator# 153406
Sudbury, Ontario, P3E 1B8
CanadaSite Not Available
Alabama Clinical Therapeutics, LLC /ID# 152258
Birmingham, Alabama 35235-3430
United StatesSite Not Available
Choice Research, LLC /ID# 150988
Dothan, Alabama 36303
United StatesSite Not Available
Brown, Pearson, Guepet Gynecology /ID# 151020
Fairhope, Alabama 36532
United StatesSite Not Available
Mobile, Ob-Gyn, P.C. /ID# 144294
Mobile, Alabama 36608
United StatesSite Not Available
Mesa Obstetricians and Gynecol /ID# 149139
Mesa, Arizona 85209
United StatesSite Not Available
Visions Clinical Research-Tucs /ID# 151017
Tucson, Arizona 85712
United StatesSite Not Available
Core Healthcare Group /ID# 151016
Cerritos, California 90703
United StatesSite Not Available
Diagnamics Inc. /ID# 152469
Encinitas, California 92024
United StatesSite Not Available
HCP Clinical Research LLC /ID# 154434
Huntington Beach, California 92646
United StatesSite Not Available
Alliance Research Centers /ID# 149752
Laguna Hills, California 92653-3621
United StatesSite Not Available
University of California, Los Angeles /ID# 149760
Los Angeles, California 90095
United StatesSite Not Available
Futura Research, Inc. /ID# 149759
Norwalk, California 90650
United StatesSite Not Available
Healthcare Partners Med Group /ID# 154434
Redondo Beach, California 90277-3416
United StatesSite Not Available
Farid Yasharpour MD Medical Co /ID# 149770
San Fernando, California 91340
United StatesSite Not Available
Quest Clinical Research /ID# 149755
San Francisco, California 94115
United StatesSite Not Available
University of California, Los Angeles /ID# 149760
Santa Monica, California 90404
United StatesSite Not Available
Healthcare Partners Med Group
Torrance, California 90503
United StatesSite Not Available
Clinical Trial Investigators /ID# 152470
Tustin, California 92780
United StatesSite Not Available
Bayview Research Group LLC /ID# 153799
Valley Village, California 91607
United StatesSite Not Available
Emerson Clinical Research Inst /ID# 152348
Washington, District of Columbia 20011
United StatesSite Not Available
Emerson Clinical Research Institute /ID# 152348
Washington, D.C., District of Columbia 20011
United StatesSite Not Available
Ideal Clinical Research Inc. /ID# 149757
Aventura, Florida 33180
United StatesSite Not Available
Seffner Premier Health Care, P /ID# 167480
Brandon, Florida 33510
United StatesSite Not Available
Olympian Clinical Research /ID# 149756
Clearwater, Florida 33756
United StatesSite Not Available
KO Clinical Research, LLC /ID# 144299
Fort Lauderdale, Florida 33316
United StatesSite Not Available
University of Florida /ID# 149751
Gainesville, Florida 32610
United StatesSite Not Available
Solutions Through Adv Rch /ID# 151021
Jacksonville, Florida 32256
United StatesSite Not Available
Meridien Research /ID# 167100
Kenneth City, Florida 33709-3113
United StatesSite Not Available
Axcess Medical Research /ID# 149769
Loxahatchee, Florida 33470
United StatesSite Not Available
Axcess Medical Research /ID# 149769
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
Invictus Clinical Research Group,LLC /ID# 141859
Miami, Florida 33144
United StatesSite Not Available
Precision Research Org, LLC /ID# 144335
Miami Lakes, Florida 33016-1501
United StatesSite Not Available
Suncoast Clinical Research /ID# 149765
New Port Richey, Florida 34652
United StatesSite Not Available
Ideal Clinical Research Inc. /ID# 149757
North Miami Beach, Florida 33162
United StatesSite Not Available
Alliance Womens Health
Orlando, Florida 32806
United StatesSite Not Available
All Wmns HC of West Broward /ID# 144298
Plantation, Florida 33324
United StatesSite Not Available
Martin Health System Center for Clinical Research /ID# 152263
Port Saint Lucie, Florida 34987
United StatesSite Not Available
Martin Health System Center for Clinical Research /ID# 152263
Port St. Lucie, Florida 34987
United StatesSite Not Available
Oncova Clinical Research, Inc. /ID# 149764
Saint Cloud, Florida 34769
United StatesSite Not Available
Meridien Research
Saint Petersburg, Florida 33709
United StatesSite Not Available
Physician Care Clin. Res., LLC /ID# 149766
Sarasota, Florida 34239
United StatesSite Not Available
Qps-Mra, Llc /Id# 144325
South Miami, Florida 33143
United StatesSite Not Available
Martin Health System Center /ID# 152263
Stuart, Florida 34994
United StatesSite Not Available
University of South Florida /ID# 149754
Tampa, Florida 33612
United StatesSite Not Available
Axcess Medical Research /ID# 149769
Wellington, Florida 33414
United StatesSite Not Available
Virtus Research Consultant,LLC /ID# 144296
Wellington, Florida 33414
United StatesSite Not Available
Paramount Research Solutions /ID# 149291
Alpharetta, Georgia 30005
United StatesSite Not Available
Agile Clinical Research Trials /ID# 167074
Atlanta, Georgia 30328
United StatesSite Not Available
Atlanta Women's Research Inst /ID# 144303
Atlanta, Georgia 30342
United StatesSite Not Available
Mount Vernon Clinical Res, LLC /ID# 144297
Atlanta, Georgia 30328
United StatesSite Not Available
Georgia Regents University /ID# 144295
Augusta, Georgia 30912
United StatesSite Not Available
Masters of Clinical Research, Inc. /ID# 167400
Augusta, Georgia 30909
United StatesSite Not Available
Mount Vernon Clinical Research, LLC /ID# 144297
Sandy Springs, Georgia 30328
United StatesSite Not Available
Meridian Clinical Research, LLC /ID# 149144
Savannah, Georgia 31406-2675
United StatesSite Not Available
Gyn-Care, Inc. /ID# 149341
Smyrna, Georgia 30080
United StatesSite Not Available
Atlanta Gynecology Research Institute /ID# 151014
Suwanee, Georgia 30024-7159
United StatesSite Not Available
Womens Healthcare Assoc, DBA /ID# 149762
Idaho Falls, Idaho 83404
United StatesSite Not Available
Advanced Clinical Research /ID# 149767
Meridian, Idaho 83642
United StatesSite Not Available
Women's Health Practice
Champaign, Illinois 61820
United StatesSite Not Available
University of Chicago /ID# 152257
Chicago, Illinois 60637-1443
United StatesSite Not Available
Affinity Clinical Research /ID# 167119
Oak Brook, Illinois 60523
United StatesSite Not Available
Center for Women's Research, Inc /ID# 144300
Palos Heights, Illinois 60463-1440
United StatesSite Not Available
Women's Health Advantage /ID# 144301
Fort Wayne, Indiana 46825
United StatesSite Not Available
Lafayette Clinical Research Group /ID# 144313
Lafayette, Indiana 47905
United StatesSite Not Available
The Iowa Clinic /ID# 150105
West Des Moines, Iowa 50266
United StatesSite Not Available
PRN Professional Research Network of Kansas, LLC /ID# 152265
Wichita, Kansas 67205
United StatesSite Not Available
Bluegrass Clinical Research /ID# 150103
Louisville, Kentucky 40291
United StatesSite Not Available
Clinical Trials Management, LLC - Covington /ID# 144314
Covington, Louisiana 70433
United StatesSite Not Available
Clinical Trials Management, LLC /ID# 144314
Mandeville, Louisiana 70471
United StatesSite Not Available
Clinical Trials Management,LLC
Metairie, Louisiana 70006
United StatesSite Not Available
Women Under Study, LLC /ID# 144312
New Orleans, Louisiana 70125-1923
United StatesSite Not Available
Baltimore Suburban Health /ID# 154638
Baltimore, Maryland 21208
United StatesSite Not Available
Womens Health Center /ID# 154209
Glen Burnie, Maryland 21063
United StatesSite Not Available
Maryland Ctr for Sexual Health /ID# 149778
Lutherville, Maryland 21093
United StatesSite Not Available
Baltimore Suburban Health /ID# 154638
Pikesville, Maryland 21208
United StatesSite Not Available
NECCR of Fall River, LLC /ID# 149584
Fall Revier, Massachusetts 02720
United StatesSite Not Available
NECCR Fall River LLC /ID# 149584
Fall River, Massachusetts 02720-2972
United StatesSite Not Available
Saginaw Valley Med Res Group /ID# 149768
Saginaw, Michigan 48604
United StatesSite Not Available
Accent Clinical Trials /ID# 149753
Henderson, Nevada 89052
United StatesSite Not Available
Accent Clinical Trials /ID# 149753
Las Vegas, Nevada 89106-4017
United StatesSite Not Available
Jersey Shore University Medical Center /ID# 149779
Neptune, New Jersey 07753-4859
United StatesSite Not Available
Jersey Shore University Medical Center /ID# 149779
Neptune City, New Jersey 07753
United StatesSite Not Available
Rowan University SOM /ID# 152697
Stratford, New Jersey 08084
United StatesSite Not Available
Montefiore Medical Center /ID# 149582
Bronx, New York 10461
United StatesSite Not Available
SUNY Downstate Medical Center /ID# 144311
Brooklyn, New York 11203
United StatesSite Not Available
Manhattan Medical Research /ID# 167077
New York, New York 10016-6023
United StatesSite Not Available
Weill Cornell Medicine /ID# 149585
New York, New York 10032-3725
United StatesSite Not Available
Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
Fayetteville, North Carolina 28304
United StatesSite Not Available
Unified Women's Clinical Research-Greensboro /ID# 149588
Greensboro, North Carolina 27408
United StatesSite Not Available
Pinewest Ob-Gyn, Inc. /ID# 145671
High Point, North Carolina 27262
United StatesSite Not Available
Eastern Carolina Women's Centr /ID# 144309
New Bern, North Carolina 28562
United StatesSite Not Available
Wake Research Associates, LLC /ID# 144307
Raleigh, North Carolina 27612
United StatesSite Not Available
Wilmingtnon Health, PLLC /ID# 167335
Wilmington, North Carolina 28401
United StatesSite Not Available
Clinical Inquest Center Ltd /ID# 148728
Beavercreek, Ohio 45432
United StatesSite Not Available
CTI Clinical Research Center /ID# 149761
Cincinnati, Ohio 45212
United StatesSite Not Available
The Christ Hospital /ID# 150104
Cincinnati, Ohio 45219
United StatesSite Not Available
Alpha Research Associates LLC /ID# 152471
Dayton, Ohio 45417
United StatesSite Not Available
Comprehensive Womens Care /ID# 144306
Westerville, Ohio 43081
United StatesSite Not Available
Oregon Health & Science University (OHSU) /ID# 144308
Portland, Oregon 97239
United StatesSite Not Available
Family Medical Associates /ID# 145668
Levittown, Pennsylvania 19056
United StatesSite Not Available
Clinical Research of Philadelphia, LLC /ID# 151015
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
University of Pennsylvania /ID# 149586
Philadelphia, Pennsylvania 19104-5502
United StatesSite Not Available
Reading Hosp Clncl Trials Ofc /ID# 149583
West Reading, Pennsylvania 19611
United StatesSite Not Available
Holston Medical Group /ID# 149763
Bristol, Tennessee 37620-7346
United StatesSite Not Available
Chattanooga Medical Research /ID# 145667
Chattanooga, Tennessee 37404
United StatesSite Not Available
Chattanooga Women for Women
Hixon, Tennessee 37343
United StatesSite Not Available
Chattanooga Women for Women /ID# 167051
Hixson, Tennessee 37343-3992
United StatesSite Not Available
The Jackson Clinic, PA /ID# 145670
Jackson, Tennessee 38305
United StatesSite Not Available
The Womens Physician Group /ID# 144317
Memphis, Tennessee 38104
United StatesSite Not Available
Access Clinical Trials, Inc. /ID# 167333
Nashville, Tennessee 37203
United StatesSite Not Available
Lotus Gynecology /ID# 149140
Austin, Texas 78703-1448
United StatesSite Not Available
Inquest Clinical Research /ID# 149755
Baytown, Texas 77521-2415
United StatesSite Not Available
Texas Health Presbyterian Hosp /ID# 149142
Dallas, Texas 75231
United StatesSite Not Available
Baylor Research Institute /ID# 149141
Fort Worth, Texas 76104
United StatesSite Not Available
Willowbend Health and Wellness Associates /ID# 144318
Frisco, Texas 75035
United StatesSite Not Available
BI Research Center /ID# 149143
Houston, Texas 77084
United StatesSite Not Available
Baylor College of Medicine /ID# 149141
Houston, Texas 77030-3411
United StatesSite Not Available
Centex Studies, Inc. - Houston /ID# 150106
Houston, Texas 77058
United StatesSite Not Available
The Woman's Hospital of Texas /ID# 144319
Houston, Texas 77054
United StatesSite Not Available
FMC Science /ID# 151802
Lampasas, Texas 76550
United StatesSite Not Available
Willowbend Health and Wellness /ID# 144318
Plano, Texas 75035
United StatesSite Not Available
Clinical Trials of Texas,Inc. /ID# 144322
San Antonio, Texas 78229
United StatesSite Not Available
Houston Ctr for Clin Research
Sugar Land, Texas 77479
United StatesSite Not Available
Center of Reproductive Medicin /ID# 167235
Webster, Texas 77598
United StatesSite Not Available
Southampton Women's Health /ID# 152325
Franklin, Virginia 23851
United StatesSite Not Available
Clinical Research Partners, LL
Henrico, Virginia 23233
United StatesSite Not Available
Tidewater Physicians for Women /ID# 144321
Norfolk, Virginia 23502
United StatesSite Not Available
Clinical Research Partners, LL /ID# 167064
North Chesterfield, Virginia 23235-4722
United StatesSite Not Available
Alliance Womens Health /ID# 152468
Richmond, Virginia 23226-1930
United StatesSite Not Available
Clinical Research Partners, LLC /ID# 144310
Richmond, Virginia 23220-4459
United StatesSite Not Available
Zain Research /ID# 151018
Richland, Washington 99352
United StatesSite Not Available
Virginia Mason Medical Center /ID# 149758
Seattle, Washington 98101
United StatesSite Not Available
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