Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-associated Pain



Status:Completed
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 50
Updated:1/7/2018
Start Date:May 27, 2014
End Date:May 23, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

A randomized study evaluating the continued safety and efficacy of elagolix in the management
of moderate to severe endometriosis associated pain in adult pre-menopausal female subjects
who completed 6 months treatment in Study M12-671.


Inclusion Criteria:

- Subject has completed the 6-Month Treatment Period in pivotal study M12-671.

- Agrees to use required birth control methods during the study through Month 6 of the
Post-treatment Follow-up period

Exclusion Criteria:

- Clinically significant condition

- Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine,
femoral neck or total hip

- Plans to become pregnant in the next 18 months
We found this trial at
84
sites
Penn State Univ and Milton S. Hershey Medical Center /ID# 121934
500 University Drive
Hershey, Pennsylvania 17033
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Hershey, PA
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Southwest Clinical Research /ID# 144087
Albuquerque, New Mexico 87109
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Albuquerque, NM
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ClinSite, LLC /ID# 134970
24 Frank Lloyd Wright Drive
Ann Arbor, Michigan 48106
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Ann Arbor, MI
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Agile Clinical Research Trials, LLC /ID# 138070
750 Hammond Drive Northeast
Atlanta, Georgia 30342
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Atlanta, GA
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Atlanta Womens Research Institute /ID# 122016
5780 Peachtree Dunwoody Road
Atlanta, Georgia 30342
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Atlanta, GA
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Augusta University /ID# 121930
Augusta, Georgia 30912
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Augusta, GA
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Boise Family Medical Center /ID# 122015
10798 West Overland Road
Boise, Idaho 83709
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Boise, ID
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Holston Medical Group (Seasons of Bristol) /ID# 131593
240 Medical Park Boulevard
Bristol, Tennessee 37620
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Bristol, TN
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SUNY Downstate Medical Center, Univ Hosp Brooklyn /ID# 134871
450 Clarkson Avenue
Brooklyn, New York 11203
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Brooklyn, NY
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PMG Research of Charlotte, LLC /ID# 122004
1700 Abbey Place
Charlotte, North Carolina 28209
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Charlotte, NC
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Chattanooga Medical Research, LLC /ID# 134969
2341 McCallie Avenue
Chattanooga, Tennessee 37404
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Chattanooga, TN
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Reliance Institute of Clinical Research /ID# 145866
5050 palozerde street
Chino, California 91710
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Chino, CA
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Katz and Kade, Inc /ID# 145606
71 East Hollister Street
Cincinnati, Ohio 45219
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Cincinnati, OH
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Community Research, Inc. /ID# 121976
Cincinnati, Ohio 45227
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Cincinnati, OH
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Comprehensive Womens Care of Colorado Springs /ID# 135119
175 South Union Boulevard
Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Vista Clinical Research /ID# 121965
Columbia, South Carolina 29201
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Columbia, SC
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Columbus Urology Research, LLC / Columbus Urology Inc /ID# 121939
Columbus, Ohio 43221
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Columbus, OH
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Nature Coast Clinical Research, LLC /ID# 121980
6122 West Corporate Oaks Drive
Crystal River, Florida 34429
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Crystal River, FL
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Cullman Clinical Research /ID# 136428
1912 Alabama 157
Cullman, Alabama 35058
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Cullman, AL
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DCT-Genesis Health Central Womens Care LLC /ID# 130249
Dallas, Texas 75231
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Dallas, TX
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Wright State University, School of Medicine /ID# 122005
Dayton, Ohio 45409
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Dayton, OH
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Advanced Women's Health Institute /ID# 138467
425 South Cherry Street
Denver, Colorado 80246
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Denver, CO
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Corner Canyon Obstetrics and Gynecology /ID# 140781
Draper, Utah 84020
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Draper, UT
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NECCR of Fall River, LLC /ID# 121951
1565 North Main Street
Fall River, Massachusetts 02720
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Fall River, MA
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Women's Health Advantage /ID# 121990
Fort Wayne, Indiana 46825
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Fort Wayne, IN
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Willowbend Health and Wellness Associates /ID# 136052
4401 Coit Road
Frisco, Texas 75035
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Frisco, TX
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Grand Rapids Women's Health /ID# 136268
Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Pinewest Ob-Gyn, Inc. /ID# 121968
306 West Westwood Avenue
High Point, North Carolina 27262
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High Point, NC
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The Woman's Hospital of Texas Clinical Research Center /ID# 135890
Houston, Texas 77054
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Houston, TX
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Jacksonville Center for Clinical Research /ID# 121985
4085 University Boulevard South
Jacksonville, Florida 32216
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Jacksonville, FL
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NEA Baptist Womens Clinic /ID# 121944
Jonesboro, Arkansas 72401
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Jonesboro, AR
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Lafayette Clinical Research Group /ID# 121989
3920 Saint Francis Way
Lafayette, Indiana 47905
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Lafayette, IN
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Altus Research, Inc /ID# 121955
4671 South Congress Avenue
Lake Worth, Florida 33461
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Lake Worth, FL
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Red Rocks OB/GYN /ID# 138093
255 Union Boulevard
Lakewood, Colorado 80228
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Lakewood, CO
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Arkansas Primary Care Clinics, PA /ID# 143838
Little Rock, Arkansas 72204
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Little Rock, AR
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The Womens Physician Group /ID# 133248
1469 Poplar Avenue
Memphis, Tennessee 38104
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Memphis, TN
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Southern Clinical Research Associates, LLC /ID# 122675
4720 South I-10 Service Road West
Metairie, Louisiana 70001
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Metairie, LA
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School of Clinical Research, LLC /ID# 121916
7309 West Flagler Street
Miami, Florida 33144
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Miami, FL
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Miami Dade Medical Research Institute, LLC /ID# 121963
8955 Southwest 87th Court
Miami, Florida 33176
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Miami, FL
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Precision Research Organization, LLC. /ID# 131614
14390 Commerce Way
Miami Lakes, Florida 33016
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Miami Lakes, FL
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Ocean Blue Medical Research Center, Inc. /ID# 121994
286 Westward Drive
Miami Springs, Florida 33166
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Miami Springs, FL
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Mobile Bay OB/GYN Center, PC /ID# 121922
3 Mobile Infirmary Circle
Mobile, Alabama 36607
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Mobile, AL
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Magnolia Ob/Gyn Research Center /ID# 136838
8203 Nigels Drive
Myrtle Beach, South Carolina 29572
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Myrtle Beach, SC
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Access Clinical Trials, Inc. /ID# 121931
2201 Murphy Avenue
Nashville, Tennessee 37203
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Nashville, TN
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Ochsner Baptist OB/GYN Clinic /ID# 121938
2700 Napoleon Avenue
New Orleans, Louisiana 70115
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Advanced Research Institute, Inc. /ID# 121973
7114 Congress Street
New Port Richey, Florida 34653
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New Port Richey, FL
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Columbia University Medical Center /ID# 121952
New York, New York 10032
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The Group for Women /ID# 122001
880 Kempsville Road
Norfolk, Virginia 23502
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Norfolk, VA
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Futura Research, Inc. /ID# 121967
Norwalk, California 90650
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Norwalk, CA
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Institute for the Study and Treatment of Endometriosis /ID# 137659
2425 West 22nd Street
Oak Brook, Illinois 60523
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Oak Brook, IL
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Excell Research, Inc /ID# 121961
3998 Vista Way
Oceanside, California 92056
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Oceanside, CA
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Focus On Women /ID# 121936
Phoenix, Arizona 85032
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Phoenix, AZ
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Central Utah Clinic /ID# 140603
1886 West 800 North
Pleasant Grove, Utah 84062
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Pleasant Grove, UT
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Lyndhurst Clinical Research /ID# 121957
Raleigh, North Carolina 27607
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Raleigh, NC
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Clinical Research Partners, LLC /ID# 121964
9920 Independence Park Drive
Richmond, Virginia 23225
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Richmond, VA
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Clinical Trials of Virginia, Inc. /ID# 132234
6767 Forest Hill Avenue
Richmond, Virginia 23225
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Richmond, VA
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Instituto Medico de la Fundacion Estudios Clinicos /ID# 122042
Rosario, Sante Fe CP S2000
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Rosario,
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Old Farm Obstetrics and Gynecology, LLC /ID# 121978
Salt Lake City, Utah 84107
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Salt Lake City, UT
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Univ of Texas Health Science Center San Antonio /ID# 121983
7703 Floyd Curl Drive
San Antonio, Texas 78229
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Clinical Trials of Texas, Inc. /ID# 134048
7940 Floyd Curl Drive
San Antonio, Texas 78229
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Clinical Trials of Texas, Inc. /ID# 135898
7940 Floyd Curl Drive
San Antonio, Texas 78229
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DCT - Stone Oak, LLC dba Discovery Clinical Trials /ID# 121958
San Antonio, Texas 78258
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West Coast Medical Research, Inc. /ID# 121984
7695 Cardinal Court
San Diego, California 92123
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San Diego, CA
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Women's Health Care Research, Corp. /ID# 121979
3750 Convoy Street
San Diego, California 92123
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San Diego, CA
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Scripps Clinic - Clinical Research /ID# 121950
11025 North Torrey Pines Road
San Diego, California 92130
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Northeast Clinical Research of San Antonio /ID# 145613
Schertz, Texas 78154
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Schertz, TX
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Seattle Women's Health, Research, Gynecology /ID# 135974
3216 Northeast 45th Place
Seattle, Washington 98105
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Seattle, WA
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GTC Research /ID# 138161
Shawnee Mission, Kansas 66218
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Shawnee Mission, KS
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Omni Fertility and Laser Institute /ID# 121999
Shreveport, Louisiana 71118
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Shreveport, LA
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Southern Pines Womens Health Center P.C. /ID# 121921
145 Applecross Road
Southern Pines, North Carolina 28388
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Southern Pines, NC
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Wayne State University /ID# 121977
Southfield, Michigan 48034
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Southfield, MI
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North Spokane Women's Health /ID# 134035
235 East Rowan Avenue
Spokane, Washington 99207
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Spokane, WA
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Richmond OB/GYN Associates PC /ID# 143850
Staten Island, New York 10306
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Staten Island, NY
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AC Clinical Research /ID# 121925
Tiffin, Ohio 44883
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Tiffin, OH
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University of Toledo /ID# 121959
3000 Arlington Avenue
Toledo, Ohio 43614
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Toledo, OH
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Oklahoma State University Center for Health Sciences /ID# 121949
1111 West 17th Street
Tulsa, Oklahoma 74127
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Tulsa, OK
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James A. Simon, MD, PC /ID# 121988
Washington, District of Columbia 20036
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Washington,
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Center of Reproductive Medicine /ID# 147380
1015 Medical Center Boulevard
Webster, Texas 77598
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Webster, TX
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Visions Clinical Research /ID# 139514
Wellington, Florida 33414
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Wellington, FL
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The Iowa Clinic /ID# 141585
5950 University Avenue
West Des Moines, Iowa 50266
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West Des Moines, IA
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Comprehensive Clinical Trials, LLC /ID# 132884
603 Village Boulevard
West Palm Beach, Florida 33409
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West Palm Beach, FL
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Cypress Medical Research Center /ID# 121941
9300 East 29th Street North
Wichita, Kansas 67226
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Wichita, KS
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PMG Research of Wilmington LLC /ID# 131688
1907 Tradd Court
Wilmington, North Carolina 28401
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Wilmington, NC
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Lyndhurst Clinical Research /ID# 121972
Winston-Salem, North Carolina 27103
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