Trial Condition(s):

Uterine Fibroids

Assess safety and efficacy of Vilaprisan in subjects with uterine fibroids (ASTEROID 6)

Bayer Identifier:

16953

ClinicalTrials.gov Identifier:

NCT03194646

EudraCT Number:

2016-004822-41

EU CT Number:

Not Available

Recruitment Complete

Trial Purpose

The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Inclusion Criteria
-18 years or older
-Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
- At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
-Good general health
-Normal or clinically insignificant cervical smear
-An endometrial biopsy performed during the screening period, without significant histological disorder 
-Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
Exclusion Criteria
-Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
-Hypersensitivity to any ingredient of the study drug
-Any condition requiring immediate blood transfusion
-Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug 
-Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
-Abuse of alcohol, drugs, or medicines (eg, laxatives)
-Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 
-Undiagnosed abnormal genital bleeding

Trial Summary

Enrollment Goal
1272
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

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Lyndhurst Clinical Research

Winston-Salem, United States, 27103

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Unified Women's Clinical Research - Morehead City

Morehead City, United States, 28557

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Carolina Women's Research & Wellness Center

Durham, United States, 27713

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Visions Clinical Research - Tucson

Tucson, United States, 85712

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Columbia University Medical Center

New York, United States, 10032

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Helix Biomedics, LLC

Boynton Beach, United States, 33435

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Advances in Health, Inc.

Houston, United States, 77030

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Unified Women’s Clinical Research - Greensboro

Greensboro, United States, 27408

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HWC Women’s Research Center

Englewood, United States, 45322

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The Woman's Hospital of Texas

Houston, United States, 77054

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Medical Center for Clinical Research

San Diego, United States, 92120

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Centex Studies, Inc.

Houston, United States, 77058

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Signature GYN Services, Pllc

Fort Worth, United States, 76104-4145

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Wake Research, Inc.

Raleigh, United States, 27612

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Willowbend Health and Wellness Associates

Plano, United States, 75093

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Miami Valley Hospital

Dayton, United States, 45409-2793

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Tidewater Physicians for Women

Norfolk, United States, 23502

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OB-GYN Physicians, Inc.

Franklin, United States, 23851

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Fellows Research Alliance - Savannah

Savannah, United States, 31406

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Southern Clinical Research Associates LLC

Metairie, United States, 70001

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PMG Research of Wilmington

Wilmington, United States, 28401

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Carolinas Healthcare System

Charlotte, United States, 28204

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Advanced Women's Health Institute

Greenwood Village, United States, 80111

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Seven Oaks Women’s Center

San Antonio, United States, 78229

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University of Arkansas for Medical Sciences

Little Rock, United States, 72205

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Paramount Research Solutions-College Park

College Park, United States, 30349

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Physicians Research Options, LLC

Lakewood, United States, 80228

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Wake Research - Clinical Research Center of Nevada, LLC

Las Vegas, United States, 89123

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Johns Hopkins University School of Medicine

Baltimore, United States, 21205

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Solutions Through Advanced Research, Inc.

Jacksonville, United States, 32256

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Atlanta Women's Research Institute, Inc. - Atlanta

Atlanta, United States, 30342

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Richmond ObGyn Associates PC

Staten Island, United States, 10306

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Augusta University Medical Center

Augusta, United States, 30912

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Medisense Inc at Atlantic Station

Atlanta, United States, 30364

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Suncoast Clinical Research

Palm Harbor, United States, 34684

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Professional Research Network of Kansas, LLC

Wichita, United States, 67205-1138

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West Coast OB/GYN Associates

San Diego, United States, 92123

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Peking Union Medical College Hospital CAMS

Beijing, China, 100730

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Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.

Beijing, China, 100026

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The First Affiliated Hospital of Dalian Medical University

Dalian, China, 116011

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Beijing Hospital of Traditional Chinese Medicine

Beijing, China, 100010

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The First Hospital of Jilin University

Changchun City, China, 130061

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Tianjin Central Hospital of Gynecology obstetrics

Tianjin, China, 300199

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Women's Clinic of Lincoln, PC

Lincoln, United States, 68510

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Discovery Clinical Trials - Dallas

Dallas, United States, 75231

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Coastal Clinical Research, Inc

Mobile, United States, 36608

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M & O Clinical Research, LLC

Ft. Lauderdale, United States, 33316

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Virginia Physicians For Women

North Chesterfield, United States, 23235

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Lawrence OB/GYN Associates

Lawrenceville, United States, 08648

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Clinical Trials of Viriginia

Richmond, United States, 23225

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Journey Medical Research

Snellville, United States, 30078

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Oregon Health and Science University

Portland, United States, 97239

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Wayne State University Physicians Group

Detroit, United States, 48201

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Agile Clinical Research Trials, LLC

Atlanta, United States, 30328

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Bosque Womens Care

Albuquerque, United States, 87109

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Axcess Medical Research, LLC

Loxahatchee, United States, 33470

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Stamford Hospital

Stamford, United States, 06904

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Office of Dr. Delbert Alan Johns, MD

Fort Worth, United States, 76104

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Suncoast Clinical Research Center, Inc.

New Port Richey, United States, 34652

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Yale University School of Medicine

New Haven, United States, 06511

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Lynn Institute of the Ozarks

Little Rock, United States, 72204

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Swor Women's Care

Sarasota, United States, 34239

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SUNY Downstate Medical Center

Brooklyn, United States, 11203

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Center For Women's Research

Palos Heights, United States, 60463

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Continental Clinical Solutions, LLC

Towson, United States, 21204

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Diagnamics, Inc.

Encinitas, United States, 92024

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Vista Clinical Research

Columbia, United States, 29201

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The 2nd Hospital of Hebei Medical University

Shijiazhuang, China, 050000

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Women's Health Alliance

Raleigh, United States, 27607

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MultiCare Health Systems Women's Health Care

Tacoma, United States, 98402

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Omni Fertility and Laser Institute

Shreveport, United States, 71118

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Office of Dr. James A. Simon, MD

Washington, United States, 20036

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Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033-0850

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Drexel University College of Medicine

Philadelphia, United States, 19102

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Hospital of the University of Pennsylvania

Philadelpahia, United States, 19104

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Valaoras & Lewis OB/GYN

Winston-Salem, United States, 27103

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Research Integrity, LLC

Owensboro, United States, 42303

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Central Research Associates, Inc.

Birmingham, United States, 35205

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ClinSearch, LLC

Chattanooga, United States, 37421

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Women's Physician Group

Memphis, United States, 38104

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VitaLink Research - Greenville

Greenville, United States, 29615

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MacArthur OB/GYN Mangement, LLC

Irving, United States, 75062

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Grossmont Center for Clinical Research

La Mesa, United States, 91942

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Venus Gynecology, LLC former Magnolia OB/GYN Research Center

Myrtle Beach, United States, 29572

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Women's Medical Research Group, LLC

Clearwater, United States, 33759

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Baltimore Suburban Health, LLC

Pikesville, United States, 21208

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Medical University of South Carolina

Charleston, United States, 29425

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Synexus Research, LLC

Richmond, United States, 23226

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Invocare Clinical Research Center, LLC

West Columbia, United States, 29169

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ONCOVA Clinical Research, Inc.

Saint Cloud, United States, 34769

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Family Medicine Clinic

Lampasas, United States, 76550

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Womens Health Care Research Corporation

San Diego, United States, 92111

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Manhattan Medical Research

New York, United States, 10016

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Eastern Carolina Women's Center

New Bern, United States, 28562

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Jersey Shore University Medical Center

Neptune, United States, 07753

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Scien. Res. Institute of Obsterics, Gyn. & Reproduction

St. Petersburg, Russia, 199034

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"Granti-Med"

St. Petersburg, Russia, 198329

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St. Petersburg Medical University n.a. I.P. Pavlov

St. Petersburg, Russia, 197022

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City Clinical Hospital #13 Moscow

Moscow, Russia, 115280

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Close Joint Stock Company "Medical Company IDK"

Samara, Russia, 443067

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Regional Clinical Hospital #2

Krasnodar, Russia, 350012

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Endocrinology Research Center

Moscow, Russia, 117036

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Krasnoyarsk regional perinatal center

Krasnoyarsk, Russia, 660074

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Scientific Center of family health & human reprod. problems

Irkutsk, Russia, 664003

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Peking University First Hospital

Beijing, China

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SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.

Guangzhou, China, 510120

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Wuhan Tongji Reproductive Medicine Hospital

Wuhan, China, 430013

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First Teaching Hosptial of Tianjin University of TCM

Tianjin, China, 300193

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Tianjin Medical University General Hospital

Tianjin, China, 300052

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Centrum gynekologicke rehabilitace

Pisek, Czech Republic, 39701

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Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

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G-Centrum Olomouc s.r.o. Dr. Skrivanek

Olomouc, Czech Republic, 772 00

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Fakultni Nemocnice Hradec Kralove

Hradec Kralove, Czech Republic, 50005

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Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 77900

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Dr. Smrhova-Kovacs

Tabor, Czech Republic, 39003

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Clinical Inquest Center, Ltd.

Beavercreek, United States, 45432

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Praetorian Pharmaceutical Research, LLC

Marrero, United States, 70072

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Women's Health Alliance of Mobile

Mobile, United States, 36604

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Kagawa Prefectural Central Hospital

Takamatsu, Japan, 760-8557

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Ginza Yoshida Clinic

Chuo-ku, Japan, 104-0061

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Mehiläinen Kuopio

Kuopio, Finland, 70100

Locations

Lääkärikeskus Gyneko

Oulu, Finland, 90100

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Dr. Victoria Garcia & Associates, LLC Doral Medical Research

Doral, United States, 33166

Locations

Hashimoto Clinic

Sapporo, Japan, 004-0052

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Yoshio Clinic

Sapporo, Japan, 064-0808

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Iryohojinshadan Seijunkai Juno Vesta Clinic Hatta

Matsudo, Japan, 270-2267

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Medical corporation keizukai Chayamachi Ladies Clinic

Osaka, Japan, 530-0013

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Kurashiki Medical Clinic

Kurashiki, Japan, 710-0824

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Aso Iizuka Hospital

Iizuka, Japan, 820-8505

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Medical Corporation Koshinkai Nomura Clinic Namba

Osaka, Japan, 542-0076

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Medical Topia Soka Hospital

Soka, Japan, 340-0028

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SAPPORO MEDICAL CENTER, NTT East Corporation

Sapporo, Japan, 060-0061

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Ishikawa Prefectural Central Hospital

Kanazawa, Japan, 920-8530

Locations

Second Kawasaki Saiwai Clinic

Kawasaki, Japan, 212-0021

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Sapporo Shiroishi Obstetrics and Gynecology Hospital

Sapporo, Japan, 003-0005

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Sapporo West Ladies Clinic

Sapporo, Japan, 063-0061

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Chayamachi ladies Clinic Hommachi

Osaka, Japan, 541-0048

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Ena Odori Clinic

Sapporo, Japan, 060-0001

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Sei Womens Clinic

Bunkyo, Japan, 112-0014

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Suita Municipal Hospital

Suita, Japan, 564-0082

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Medical Corp. Seikoukai New Medical Research System Clinic

Hachioji, Japan, 192-0046

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Ikebukuro Metropolitan Clinic

Toshima-ku, Japan, 171-0021

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Shirokane Ladies' Clinic

Minato, Japan, 108-0071

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Yokokura Clinic

Minato-ku, Japan, 108-0014

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Women's wellness Tsushima Ruriko josei life clinic Ginza

Chuo-ku, Japan, 104-0061

Locations

Fuyo Association Seirei Numazu Hospital

Numazu, Japan, 410-8555

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St.Luke's International Hospital

Chuoku, Japan, 104-8560

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Kato Internal medicine and Gynecology Clinic

Fukui, Japan, 910-0845

Locations

Sato Hospital

Takasaki, Japan, 370-0836

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Kugayama Hospital

Setagaya-ku, Japan, 157-0061

Locations

Sano Women's Clinic

Fukuoka, Japan, 810-0062

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IZUMA CLINIC

Osaka, Japan, 543-0023

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Kano's Clinic for Women

Nagoya, Japan, 460-0011

Locations

Toranomon Womens Clinic

Minato, Japan, 105-0001

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Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic

Minato, Japan, 107-0051

Locations

Jusendo Geneal Hospital Yuasa Foundation

Koriyama, Japan, 963-8585

Locations

Akazawa Clinic

Fuchu, Japan, 183-0056

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International Peace Maternity&Child Health Hospital of CWI

Shanghai, China, 200030

Locations

West China Second University Hospital

Chengdu, China, 610041

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Beijing Tiantan Hospital, Captial Medical University

Beijing, China, 100050

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Shandong Provincial Hospital

Jinan, China, 250021

Locations

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, China, 030001

Locations

The First Affiliated Hospital of Xinjiang Medical University

Urumqi, China, 830054

Locations

Nesttun Spesialistpraksis AS

Nesttun, Norway, 5221

Locations

Kirkeparken Spesialistpraksis

Fredrikstad, Norway, 1605

Locations

Medicus AS

Trondheim, Norway, 7014

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, China, 310006

Locations

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China, 530021

Locations

Prywatna Klinika Ginekologiczno-Poloznicza

Bialystok, Poland, 15-244

Locations

Centrum Medyczne Chodzki

Lublin, Poland, 20-093

Locations

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

Locations

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, Poland, 20-400

Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

Locations

Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

Locations

Gyncentrum Sp. z o.o.

Katowice, Poland, 40-851

Locations

Zhongda Hospital Southeast University

Nanjing, China, 210009

Locations

Queen Mary Hospital

Hongkong, Hong Kong, China

Locations

Sanatorio Alcocer Pozo S. A. de C. V.

Querétaro, Mexico, 76000

Locations

Centro Integral Médico de San Juan del Río S. C.

San Juan del Río, Mexico, 76800

Locations

Dr L Reynders Practice

Lyttelton Manor, South Africa, 0141

Locations

Clintrials Centre for Clinical Research

Panorama, South Africa, 7500

Locations

Nanjing Maternity and Child Health Care Hospital

Nanjing, China, 210004

Locations

NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

Nanjing, China, 210008

Locations

Shizuoka Saiseikai General Hospital

Shizuoka, Japan, 422-8527

Locations

Unoki Clinic

Kagoshima, Japan, 892-0826

Locations

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

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Changhai Hospital of Second Military Medical University

Shanghai, China, 200433

Locations

The First Affiliated Hospital of Guangzhou University of TCM

Guangzhou, China, 510405

Locations

The Second Affliated Hospital of Wenzhou Medicial University

Wenzhou, China, 325000

Locations

The Second Affiliated Hospital of Nanchang University

Nanchang, China, 330200

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900th Hospital of Joint Logistics Support Force

Fuzhou, China, 350025

Locations

Hainan General Hospital

Haikou, China, 570311

Locations

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China, 510630

Locations

Peking University Shenzhen Hospital

Shenzhen, China, 518036

Locations

Sapporo Maternity Women's Minami1jo Clinic

Sapporo, Japan, 060-0061

Locations

Primo Women's Clinic

Ebetsu, Japan, 067-0031

Locations

Sapporo Maternity Women's Hospital

Sapporo, Japan, 001-0013

Locations

Kyoritsu Narashinodai Hospital

Funabashi, Japan, 274-0063

Locations

Shizuoka City Shimizu Hospital

Shizuoka, Japan, 424-8636

Locations

Asahi-Clinic

Takamatsu, Japan, 760-0076

Locations

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

Locations

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, Turkey, 34093

Locations

Uludag Universitesi Tip Fakultesi

Bursa, Turkey, 16059

Locations

Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey, 6100

Locations

Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast

Ankara, Turkey

Locations

Cukurova Universitesi Tip Fakultesi Hastanesi

Adana, Turkey, 01330

Locations

Femway Inc

Umhlanga, South Africa, 4321

Locations

Durban International Clinical Research Site

Wentworth, South Africa, 4052

Locations

Drs AEVITAS Clinic (Pty) Ltd

Cape Town, South Africa, 7405

Locations

University of Pretoria, Clinical Research Unit

Pretoria, South Africa, 0002

Locations

University of Cape Town Clinical Research Centre

Cape Town, South Africa, 7925

Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Locations

King Chulalongkorn Memorial Hospital

Bangkok, Thailand, 10330

Locations

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico

Locations

Henry Ford Health System

Detroit, United States, 48202

Locations

MUDr. Pavlina Nejedla s.r.o.

Vodnany, Czech Republic, 389 01

Locations

Jiangxi Maternal and Child Health Hospital

Nanchang, China, 330006

Locations

MUDr. Radek Fiker s.r.o.

Jihlava, Czech Republic, 586 01

Trial Design