Phase
Condition
Dysfunctional Uterine Bleeding
Heavy Bleeding / Heavy Periods
Sarcoma (Pediatric)
Treatment
N/AClinical Study ID
Ages 18-51 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant has completed the 6-Month Treatment Period of their respective PivotalStudy (either Study M12-815 or Study M12-817).
- Participant did not meet removal criteria in bone mineral density (BMD) decrease inthe spine, total hip and femoral neck at Month 6 of the Treatment Period of theirrespective Pivotal Study
- Participant has negative urine and/or serum pregnancy test(s) results wereconsistently negative during the Treatment Period of their respective Pivotal Studyand prior to first dose in this study.
- Participant's endometrial biopsy from the Month 6 Visit of their respective PivotalStudy shows no clinically significant endometrial pathology.
Exclusion
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 herrespective 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 torequire treatment with systemic corticosteroids during the course of the study.Over-the-counter and prescription topical, inhaled, intranasal or injectable (foroccasional use) corticosteroids are allowed.
Study Design
Connect with a study center
Victory Reproductive Care /ID# 153299
Windsor, Ontario N8W 5R7
CanadaSite Not Available
University of Puerto Rico, School of Medicine /ID# 153329
Rio Piedras, 00935
Puerto RicoSite Not Available
Rodriguez-Ginorio, San Juan /ID# 153328
San Juan, 00917
Puerto RicoSite Not Available
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329
San Juan, 00935
Puerto RicoSite Not Available
Alabama Clinical Therapeutics, LLC /ID# 153217
Birmingham, Alabama 35235-3430
United StatesSite Not Available
Alabama Clinical Therapeutics, LLC /ID# 153336
Birmingham, Alabama 35235-3430
United StatesSite Not Available
Choice Research, LLC /ID# 153492
Dothan, Alabama 36303
United StatesSite Not Available
Brown, Pearson, Guepet Gynecology /ID# 153278
Fairhope, Alabama 36532
United StatesSite Not Available
Mobile, Ob-Gyn, P.C. /ID# 153442
Mobile, Alabama 36608
United StatesSite Not Available
University of South Alabama /ID# 153415
Mobile, Alabama 36604-3302
United StatesSite Not Available
Mesa Obstetricians and Gynecol /ID# 153269
Mesa, Arizona 85209
United StatesSite Not Available
Visions Clinical Research-Tucson /ID# 153286
Tucson, Arizona 85712
United StatesSite Not Available
Core Healthcare Group /ID# 153282
Cerritos, California 90703
United StatesSite Not Available
Diagnamics Inc. /ID# 153347
Encinitas, California 92024
United StatesSite Not Available
Grossmont Ctr Clin Research /ID# 153324
La Mesa, California 91942
United StatesSite Not Available
Futura Research, Inc. /ID# 153345
Norwalk, California 90650
United StatesSite Not Available
Farid Yasharpour MD Medical Co /ID# 153482
San Fernando, California 91340
United StatesSite Not Available
Bayview Research Group /ID# 169593
Valley Village, California 91607
United StatesSite Not Available
Advanced Women's Health Instit
Denver, Colorado 80246
United StatesSite Not Available
Advanced Women's Health Institution /ID# 153401
Greenwood Village, Colorado 80111
United StatesSite Not Available
Emerson Clinical Research Inst /ID# 162755
Washington, District of Columbia 20011
United StatesSite Not Available
James A. Simon, MD, PC /ID# 153323
Washington, District of Columbia 20036
United StatesSite Not Available
Medstar Health Research Institute /ID# 153321
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center /ID# 153321
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Helix Biomedics, LLC /ID# 153440
Boynton Beach, Florida 33436-6634
United StatesSite Not Available
Brandon Premier Health Care, PA /ID# 165791
Brandon, Florida 33510-3107
United StatesSite Not Available
Florida Fertility Institute /ID# 153308
Clearwater, Florida 33759
United StatesSite Not Available
Omega Research Consultants, LLC /ID# 153381
DeBary, Florida 32713-2260
United StatesSite Not Available
KO Clinical Research, LLC /ID# 153198
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Clinical Physiology Assoc. /ID# 153444
Fort Myers, Florida 33916
United StatesSite Not Available
Solutions Through Adv Rch /ID# 153283
Jacksonville, Florida 32256
United StatesSite Not Available
Meridien Research /ID# 153310
Kenneth City, Florida 33709-3113
United StatesSite Not Available
Altus Research, Inc /ID# 153307
Lake Worth, Florida 33461
United StatesSite Not Available
Axcess Medical Research /ID# 153500
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
South Florida Wellness & Clinic /ID# 153420
Margate, Florida 33063
United StatesSite Not Available
Healthcare Clinical Data, Inc /ID# 153425
Miami, Florida 33161
United StatesSite Not Available
Invictus Clinical Research Group,LLC /ID# 153196
Miami, Florida 33144
United StatesSite Not Available
LCC Medical Research Institute /ID# 153296
Miami, Florida 33126
United StatesSite Not Available
Ocean Blue Med Research Ctr /ID# 153225
Miami, Florida 33166
United StatesSite Not Available
Precision Research Org, LLC /ID# 153276
Miami Lakes, Florida 33016-1501
United StatesSite Not Available
Ocean Blue Medical Research Center, Inc. /ID# 153225
Miami Springs, Florida 33166
United StatesSite Not Available
Advanced Research Institute /ID# 153413
New Port Richey, Florida 34653
United StatesSite Not Available
Suncoast Clinical Research /ID# 153206
New Port Richey, Florida 34652
United StatesSite Not Available
Healthcare Clinical Data, Inc. /ID# 153425
North Miami, Florida 33161
United StatesSite Not Available
Clinical Associates of Orlando /ID# 153427
Orlando, Florida 32806
United StatesSite Not Available
Unified Womens Clin Research /ID# 153229
Panama City, Florida 32045
United StatesSite Not Available
All Wmns HC of West Broward /ID# 153434
Plantation, Florida 33324
United StatesSite Not Available
Oncova Clinical Research, Inc. /ID# 153497
Saint Cloud, Florida 34769
United StatesSite Not Available
Meridien Research
Saint Petersburg, Florida 33709
United StatesSite Not Available
Physician Care Clin. Res., LLC /ID# 153210
Sarasota, Florida 34239
United StatesSite Not Available
Qps-Mra, Llc /Id# 153456
South Miami, Florida 33143
United StatesSite Not Available
Meridien Research /ID# 153310
St. Petersburg, Florida 33709
United StatesSite Not Available
University of South Florida /ID# 153271
Tampa, Florida 33612
United StatesSite Not Available
Axcess Medical Research /ID# 153500
Wellington, Florida 33414
United StatesSite Not Available
Virtus Research Consultant,LLC /ID# 153398
Wellington, Florida 33414
United StatesSite Not Available
Comprehensive Clinical Trials /ID# 153350
West Palm Beach, Florida 33409
United StatesSite Not Available
Atlanta Medical Research Insti /ID# 153298
Alpharetta, Georgia 30005-4419
United StatesSite Not Available
Paramount Research Solutions /ID# 153424
Alpharetta, Georgia 30005
United StatesSite Not Available
Paramount Research Solutions /ID# 160974
Alpharetta, Georgia 30005
United StatesSite Not Available
Atlanta Women's Research Inst /ID# 153212
Atlanta, Georgia 30342
United StatesSite Not Available
Mount Vernon Clinical Res, LLC /ID# 153403
Atlanta, Georgia 30328
United StatesSite Not Available
Masters of Clinical Research, Inc. /ID# 153295
Augusta, Georgia 30909
United StatesSite Not Available
Paramount Research Solutions /ID# 153351
College Park, Georgia 30349
United StatesSite Not Available
Mount Vernon Clinical Research, LLC /ID# 153403
Sandy Springs, Georgia 30328
United StatesSite Not Available
Fellows Research Alliance, Inc /ID# 153227
Savannah, Georgia 31406
United StatesSite Not Available
Atlanta Gynecology Research Institute /ID# 200074
Suwanee, Georgia 30024-7159
United StatesSite Not Available
Clinical Research Consultants of Atlanta /ID# 153285
Suwanee, Georgia 30024-6988
United StatesSite Not Available
Boise Family Medicine Center
Boise, Idaho 83709
United StatesSite Not Available
Sonora Clinical Research /ID# 153231
Meridian, Idaho 83646-1144
United StatesSite Not Available
The University of Chicago /ID# 153334
Chicago, Illinois 60637
United StatesSite Not Available
Affinity Clinical Research /ID# 153417
Oak Brook, Illinois 60523
United StatesSite Not Available
Women's Health Advantage /ID# 153208
Fort Wayne, Indiana 46825
United StatesSite Not Available
Bluegrass Clinical Research /ID# 153280
Louisville, Kentucky 40291
United StatesSite Not Available
Clinical Trials Management, LLC - Covington /ID# 153211
Covington, Louisiana 70433
United StatesSite Not Available
Clinical Trials Management, LLC - Covington /ID# 153439
Covington, Louisiana 70433
United StatesSite Not Available
Clinical Trials Management,LLC
Metairie, Louisiana 70006
United StatesSite Not Available
Ochsner Baptist Medical Center /ID# 153459
New Orleans, Louisiana 70115
United StatesSite Not Available
Omni Fertility and Laser Insti /ID# 153228
Shreveport, Louisiana 71118
United StatesSite Not Available
Baltimore Suburban Health /ID# 168386
Baltimore, Maryland 21208
United StatesSite Not Available
Genesis Clinical Research /ID# 153379
Fall River, Massachusetts 02720
United StatesSite Not Available
NECCR Fall River LLC /ID# 153274
Fall River, Massachusetts 02720-2972
United StatesSite Not Available
Great Lakes Research Group,Inc /ID# 153302
Bay City, Michigan 48706
United StatesSite Not Available
Saginaw Valley Med Res Group /ID# 153498
Saginaw, Michigan 48604
United StatesSite Not Available
Wayne State University Physician Group - Southfield /ID# 153418
Southfield, Michigan 48034
United StatesSite Not Available
Accent Clinical Trials /ID# 153474
Las Vegas, Nevada 89106-4017
United StatesSite Not Available
Mabey, Las Vegas, NV /ID# 153314
Las Vegas, Nevada 89128
United StatesSite Not Available
Office of Edmond E. Pack, MD /ID# 153411
Las Vegas, Nevada 89113
United StatesSite Not Available
Lawrence OB/GYN /ID# 153218
Lawrenceville, New Jersey 08648
United StatesSite Not Available
Jersey Shore University Medical Center /ID# 153495
Neptune, New Jersey 07753-4859
United StatesSite Not Available
Jersey Shore University Medical Center /ID# 153495
Neptune City, New Jersey 07753
United StatesSite Not Available
Bosque Women's Care /ID# 153223
Albuquerque, New Mexico 87109
United StatesSite Not Available
SUNY Downstate Medical Center /ID# 153344
Brooklyn, New York 11203
United StatesSite Not Available
Manhattan Medical Research /ID# 153386
New York, New York 10016-6023
United StatesSite Not Available
Weill Cornell Medicine /ID# 153275
New York, New York 10032-3725
United StatesSite Not Available
Cwrwc /Id# 153313
Durham, North Carolina 27713
United StatesSite Not Available
Unified Women's Clinical Resea /ID# 153479
Fayetteville, North Carolina 28304
United StatesSite Not Available
Unified Women's Clinical Research-Greensboro /ID# 153499
Greensboro, North Carolina 27408
United StatesSite Not Available
Pinewest Ob-Gyn, Inc. /ID# 153197
High Point, North Carolina 27262
United StatesSite Not Available
Eastern Carolina Women's Centr /ID# 153341
New Bern, North Carolina 28562
United StatesSite Not Available
Unified Women's Clinical Resea /ID# 153312
Raleigh, North Carolina 27607
United StatesSite Not Available
Wake Research Associates, LLC /ID# 153402
Raleigh, North Carolina 27612
United StatesSite Not Available
Unified Women's Clinical Resea /ID# 153297
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Clinical Inquest Center Ltd /ID# 153436
Beavercreek, Ohio 45432
United StatesSite Not Available
CTI Clinical Research Center /ID# 153201
Cincinnati, Ohio 45212
United StatesSite Not Available
University Hospitals Cleveland /ID# 153450
Cleveland, Ohio 44106
United StatesSite Not Available
Wright State University & Premier Health CTRA /ID# 153222
Fairborn, Ohio 45324
United StatesSite Not Available
University of Toledo /ID# 153409
Toledo, Ohio 43614
United StatesSite Not Available
Comprehensive Womens Care /ID# 153396
Westerville, Ohio 43081
United StatesSite Not Available
Legacy Medical Group-Portland /ID# 168286
Portland, Oregon 97210
United StatesSite Not Available
Main Line Fertility Center /ID# 153410
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available
Penn State University and Milton S. Hershey Medical Center /ID# 153443
Hershey, Pennsylvania 17033
United StatesSite Not Available
Family Medical Associates /ID# 153457
Levittown, Pennsylvania 19056
United StatesSite Not Available
Clinical Research of Philadelphia, LLC /ID# 153279
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Thomas Jefferson University /ID# 153319
Philadelphia, Pennsylvania 19107-4414
United StatesSite Not Available
University of Pennsylvania /ID# 153203
Philadelphia, Pennsylvania 19104-5502
United StatesSite Not Available
Reading Hosp Clncl Trials Ofc /ID# 153475
West Reading, Pennsylvania 19611
United StatesSite Not Available
Medical University of South Carolina /ID# 153325
Charleston, South Carolina 29425
United StatesSite Not Available
Vista Clinical Research /ID# 153399
Columbia, South Carolina 29201
United StatesSite Not Available
Chattanooga Medical Research /ID# 153405
Chattanooga, Tennessee 37404
United StatesSite Not Available
WR-ClinSearch /ID# 153404
Chattanooga, Tennessee 37421-1605
United StatesSite Not Available
Chattanooga Women for Women
Hixon, Tennessee 37343
United StatesSite Not Available
Chattanooga Women for Women /ID# 153404
Hixson, Tennessee 37343-3992
United StatesSite Not Available
Research Memphis Associates, LLC /ID# 153322
Memphis, Tennessee 38119-3895
United StatesSite Not Available
Women's Health Trials /ID# 153426
Menphis, Tennessee 38104
United StatesSite Not Available
Access Clinical Trials, Inc. /ID# 153441
Nashville, Tennessee 37203
United StatesSite Not Available
Lotus Gynecology /ID# 153476
Austin, Texas 78703-1448
United StatesSite Not Available
Texas Health Presbyterian Hosp /ID# 153339
Dallas, Texas 75231
United StatesSite Not Available
UT Southwestern Medical Center /ID# 153400
Dallas, Texas 75390-7208
United StatesSite Not Available
Baylor Scott & White /ID# 153273
Fort Worth, Texas 76104-4110
United StatesSite Not Available
Willowbend Health and Wellness /ID# 153458
Frisco, Texas 75035
United StatesSite Not Available
Advances in Health, Inc. /ID# 153414
Houston, Texas 77030
United StatesSite Not Available
The Woman's Hospital of Texas /ID# 153270
Houston, Texas 77054
United StatesSite Not Available
FMC Science /ID# 153289
Lampasas, Texas 76550
United StatesSite Not Available
Clinical Trials of Texas,Inc. /ID# 153209
San Antonio, Texas 78229
United StatesSite Not Available
Discovery Clinical Trials-San Antonio /ID# 153315
San Antonio, Texas 78258
United StatesSite Not Available
Houston Ctr for Clin Research /ID# 153221
Sugar Land, Texas 77479
United StatesSite Not Available
Center of Reproductive Medicin /ID# 153320
Webster, Texas 77598
United StatesSite Not Available
Clinical Research Partners, LL
Henrico, Virginia 23233
United StatesSite Not Available
Eastern Virginia Med School /ID# 153380
Norfolk, Virginia 23507-1627
United StatesSite Not Available
Tidewater Physicians for Women /ID# 153432
Norfolk, Virginia 23502
United StatesSite Not Available
Clinical Research Partners, LL /ID# 153412
North Chesterfield, Virginia 23235-4722
United StatesSite Not Available
Clinical Research Partners, LLC /ID# 153343
Richmond, Virginia 23220-4459
United StatesSite Not Available
Clinical Trials Virginia, Inc. /ID# 153419
Richmond, Virginia 23225
United StatesSite Not Available
Emerson Clinical Research Inst /ID# 153416
Vienna, Virginia 22182
United StatesSite Not Available
Seattle Women's Health, Research, Gynecology /ID# 153306
Seattle, Washington 98105
United StatesSite Not Available
Virginia Mason Medical Center /ID# 153342
Seattle, Washington 98101
United StatesSite Not Available
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