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Brief Title: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Official Title: An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care
Study ID: NCT03194646
Brief Summary: The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Central Research Associates | Birmingham, AL, Birmingham, Alabama, United States
Women's Health Alliance of Mobile, Mobile, Alabama, United States
Coastal Clinical Research, Inc, Mobile, Alabama, United States
Visions Clinical Research - Tucson, Tucson, Arizona, United States
Lynn Health Science Institute | Lynn Institute of the Ozarks, Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Diagnamics, Inc., Encinitas, California, United States
Grossmont Center for Clinical Research, La Mesa, California, United States
Womens Health Care Research Corporation, San Diego, California, United States
Medical Center for Clinical Research, San Diego, California, United States
West Coast OB/GYN Associates, San Diego, California, United States
Advanced Women's Health Institute, Greenwood Village, Colorado, United States
Physicians Research Options, LLC, Lakewood, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Stamford Hospital, Stamford, Connecticut, United States
Office of Dr. James A. Simon, MD, Washington, District of Columbia, United States
Helix Biomedics, LLC, Boynton Beach, Florida, United States
Women's Medical Research Group, LLC, Clearwater, Florida, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research, Doral, Florida, United States
M & O Clinical Research, LLC, Fort Lauderdale, Florida, United States
Solutions Through Advanced Research, Inc., Jacksonville, Florida, United States
Axcess Medical Research, LLC, Loxahatchee Groves, Florida, United States
Suncoast Clinical Research Center, Inc., New Port Richey, Florida, United States
Suncoast Clinical Research, Palm Harbor, Florida, United States
ONCOVA Clinical Research, Inc., Saint Cloud, Florida, United States
Swor Women's Care, Sarasota, Florida, United States
Agile Clinical Research Trials, LLC, Atlanta, Georgia, United States
Atlanta Women's Research Institute, Inc. - Atlanta, Atlanta, Georgia, United States
Medisense Inc at Atlantic Station, Atlanta, Georgia, United States
Augusta University Medical Center, Augusta, Georgia, United States
Paramount Research Solutions-College Park, College Park, Georgia, United States
Fellows Research Alliance - Savannah, Savannah, Georgia, United States
Journey Medical Research, Snellville, Georgia, United States
Center For Women's Research, Palos Heights, Illinois, United States
Professional Research Network of Kansas, LLC, Wichita, Kansas, United States
Research Integrity, LLC, Owensboro, Kentucky, United States
Praetorian Pharmaceutical Research, LLC, Marrero, Louisiana, United States
Southern Clinical Research Associates LLC, Metairie, Louisiana, United States
Omni Fertility and Laser Institute, Shreveport, Louisiana, United States
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
Baltimore Suburban Health, LLC, Pikesville, Maryland, United States
Continental Clinical Solutions | Towson, MD, Towson, Maryland, United States
Wayne State University Physicians Group, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Women's Clinic of Lincoln, PC, Lincoln, Nebraska, United States
Wake Research - Clinical Research Center of Nevada, LLC, Las Vegas, Nevada, United States
Lawrence OB/GYN Associates, Lawrenceville, New Jersey, United States
Jersey Shore University Medical Center, Neptune, New Jersey, United States
Bosque Womens Care, Albuquerque, New Mexico, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Manhattan Medical Research, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Richmond ObGyn Associates PC, Staten Island, New York, United States
Carolinas Healthcare System, Charlotte, North Carolina, United States
Carolina Women's Research & Wellness Center, Durham, North Carolina, United States
Unified Women's Clinical Research, Greensboro, North Carolina, United States
Unified Women's Clinical Research - Morehead City, Morehead City, North Carolina, United States
Eastern Carolina Women's Center, New Bern, North Carolina, United States
Women's Health Alliance, Raleigh, North Carolina, United States
Wake Research, Inc., Raleigh, North Carolina, United States
PMG Research of Wilmington, Wilmington, North Carolina, United States
Lyndhurst Clinical Research, Winston-Salem, North Carolina, United States
Valaoras & Lewis OB/GYN, Winston-Salem, North Carolina, United States
Clinical Inquest Center, Ltd., Beavercreek, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
HWC Women's Research Center | Englewood, OH, Englewood, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Drexel University College of Medicine, Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, United States
Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology, Charleston, South Carolina, United States
Vista Clinical Research, Columbia, South Carolina, United States
VitaLink Research - Greenville, Greenville, South Carolina, United States
Venus Gynecology, LLC former Magnolia OB/GYN Research Center, Myrtle Beach, South Carolina, United States
Invocare Clinical Research Center, LLC, West Columbia, South Carolina, United States
ClinSearch, LLC, Chattanooga, Tennessee, United States
Women's Physician Group, Memphis, Tennessee, United States
Discovery Clinical Trials - Dallas, Dallas, Texas, United States
Signature GYN Services, Pllc, Fort Worth, Texas, United States
Office of Dr. Delbert Alan Johns, MD, Fort Worth, Texas, United States
Family Medicine Clinic, Georgetown, Texas, United States
Advances in Health, Inc., Houston, Texas, United States
The Woman's Hospital of Texas, Houston, Texas, United States
Centex Studies, Inc., Houston, Texas, United States
MacArthur OB/GYN Mangement, LLC, Irving, Texas, United States
Willowbend Health and Wellness Associates, Plano, Texas, United States
Seven Oaks Women's Center, San Antonio, Texas, United States
OB-GYN Physicians, Inc., Franklin, Virginia, United States
Tidewater Physicians for Women, Norfolk, Virginia, United States
Virginia Physicians For Women, North Chesterfield, Virginia, United States
Clinical Trials of Viriginia, Richmond, Virginia, United States
Synexus Research, LLC, Richmond, Virginia, United States
MultiCare Health Systems Women's Health Care, Tacoma, Washington, United States
900th Hospital of Joint Logistics Support Force, Fuzhou, Fujian, China
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ., Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of TCM, Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Hainan General Hospital, Haikou, Hainan, China
The 2nd Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Wuhan Tongji Reproductive Medicine Hospital, Wuhan, Hubei, China
Nanjing Maternity and Child Health Care Hospital, Nanjing, Jiangsu, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing, Jiangsu, China
Zhongda Hospital Southeast University, Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital, Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Changchun City, Jilin, China
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
Shandong Provincial Hospital, Jinan, Shandong, China
The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
West China Second University Hospital, Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China
The Second Affliated Hospital of Wenzhou Medicial University, Wenzhou, Zhejiang, China
Beijing Hospital of Traditional Chinese Medicine, Beijing, , China
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni., Beijing, , China
Beijing Tiantan Hospital, Captial Medical University, Beijing, , China
Peking Union Medical College Hospital CAMS, Beijing, , China
Peking University First Hospital, Beijing, , China
International Peace Maternity&Child Health Hospital of CWI, Shanghai, , China
Changhai Hospital of Second Military Medical University, Shanghai, , China
Tianjin Medical University General Hospital, Tianjin, , China
First Teaching Hosptial of Tianjin University of TCM, Tianjin, , China
Tianjin Central Hospital of Gynecology obstetrics, Tianjin, , China
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni Nemocnice Hradec Kralove, Hradec Kralove, , Czechia
MUDr. Radek Fiker s.r.o., Jihlava, , Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek, Olomouc, , Czechia
Fakultni Nemocnice Olomouc, Olomouc, , Czechia
Centrum gynekologicke rehabilitace, Pisek, , Czechia
Dr. Smrhova-Kovacs, Tabor, , Czechia
MUDr. Pavlina Nejedla s.r.o., Vodnany, , Czechia
Mehiläinen Kuopio, Kuopio, , Finland
Lääkärikeskus Gyneko, Oulu, , Finland
Queen Mary Hospital, Hongkong, , Hong Kong
Kano's Clinic for Women, Nagoya, Aichi, Japan
Kyoritsu Narashinodai Hospital, Funabashi, Chiba, Japan
Juno Vesta Clinic Hatta, Matsudo, Chiba, Japan
Aso Iizuka Hospital, Iizuka, Fukuoka, Japan
Jusendo Geneal Hospital Yuasa Foundation, Koriyama, Fukushima, Japan
Sato Hospital, Takasaki, Gunma, Japan
Primo Women's Clinic, Ebetsu, Hokkaido, Japan
Sapporo Maternity Women's Hospital, Sapporo, Hokkaido, Japan
Sapporo Shiroishi Obstetrics and Gynecology Hospital, Sapporo, Hokkaido, Japan
Hashimoto Clinic, Sapporo, Hokkaido, Japan
Ena Odori Clinic, Sapporo, Hokkaido, Japan
Sapporo Maternity Women's Minami1jo Clinic, Sapporo, Hokkaido, Japan
SAPPORO MEDICAL CENTER, NTT East Corporation, Sapporo, Hokkaido, Japan
Sapporo West Ladies Clinic, Sapporo, Hokkaido, Japan
Yoshio Clinic, Sapporo, Hokkaido, Japan
Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan
Asahi-Clinic, Takamatsu, Kagawa, Japan
Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan
Second Kawasaki Saiwai Clinic, Kawasaki, Kanagawa, Japan
Kurashiki Medical Clinic, Kurashiki, Okayama, Japan
Suita Municipal Hospital, Suita, Osaka, Japan
Medical Topia Soka Hospital, Soka, Saitama, Japan
Fuyo Association Seirei Numazu Hospital, Numazu, Shizuoka, Japan
Sei Womens Clinic, Bunkyo, Tokyo, Japan
Ginza Yoshida Clinic, Chuo-ku, Tokyo, Japan
Women's wellness Tsushima Ruriko josei life clinic Ginza, Chuo-ku, Tokyo, Japan
St.Luke's International Hospital, Chuoku, Tokyo, Japan
Akazawa Clinic, Fuchu, Tokyo, Japan
Medical Corp. Seikoukai New Medical Research System Clinic, Hachioji, Tokyo, Japan
Yokokura Clinic, Minato-ku, Tokyo, Japan
Toranomon Womens Clinic, Minato, Tokyo, Japan
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic, Minato, Tokyo, Japan
Shirokane Ladies' Clinic, Minato, Tokyo, Japan
Kugayama Hospital, Setagaya-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo, Japan
Ikebukuro Metropolitan Clinic, Toshima-ku, Tokyo, Japan
Kato Internal medicine and Gynecology Clinic, Fukui, , Japan
Sano Wemen's Clinic, Fukuoka, , Japan
Unoki Clinic, Kagoshima, , Japan
Medical corporation keizukai Chayamachi Ladies Clinic, Osaka, , Japan
Chayamachi ladies Clinic Hommachi, Osaka, , Japan
Medical Corporation Koshinkai Nomura Clinic Namba, Osaka, , Japan
Izuma Clinic, Osaka, , Japan
Shizuoka Saiseikai General Hospital, Shizuoka, , Japan
Shizuoka City Shimizu Hospital, Shizuoka, , Japan
Hospital Universitario "José Eleuterio González", Monterrey, Nuevo Leon, Mexico
Centro Integral Médico de San Juan del Río S. C., San Juan del Río, Querétaro, Mexico
Sanatorio Alcocer Pozo S. A. de C. V., Querétaro, , Mexico
Kirkeparken Spesialistpraksis, Fredrikstad, , Norway
Nesttun Spesialistpraksis AS, Nesttun, , Norway
Medicus AS, Trondheim, , Norway
Prywatna Klinika Ginekologiczno-Poloznicza, Bialystok, , Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o., Katowice, , Poland
Vita Longa Sp. z o.o., Katowice, , Poland
Gyncentrum Sp. z o.o., Katowice, , Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr., Lodz, , Poland
Centrum Medyczne Chodzki, Lublin, , Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy, Lublin, , Poland
Scientific Center of family health & human reprod. problems, Irkutsk, , Russian Federation
Regional Clinical Hospital #2, Krasnodar, , Russian Federation
Krasnoyarsk regional perinatal center, Krasnoyarsk, , Russian Federation
City Clinical Hospital #13 Moscow, Moscow, , Russian Federation
Endocrinology Research Center, Moscow, , Russian Federation
Close Joint Stock Company "Medical Company IDK", Samara, , Russian Federation
St. Petersburg Medical University n.a. I.P. Pavlov, St. Petersburg, , Russian Federation
"Granti-Med", St. Petersburg, , Russian Federation
Scien. Res. Institute of Obsterics, Gyn. & Reproduction, St. Petersburg, , Russian Federation
Dr L Reynders Practice, Lyttelton Manor, Gauteng, South Africa
University of Pretoria, Clinical Research Unit, Pretoria, Gauteng, South Africa
Femway Inc, Umhlanga, Kwazulu-Natal, South Africa
Durban International Clinical Research Site, Wentworth, Kwazulu-Natal, South Africa
Drs AEVITAS Clinic (Pty) Ltd, Cape Town, Western Cape, South Africa
University of Cape Town Clinical Research Centre, Cape Town, Western Cape, South Africa
Clintrials Centre for Clinical Research, Panorama, Western Cape, South Africa
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Siriraj Hospital, Mahidol, Bangkok, , Thailand
Cukurova Universitesi Tip Fakultesi Hastanesi, Adana, , Turkey
Ankara Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast, Ankara, , Turkey
Uludag Universitesi Tip Fakultesi, Bursa, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul, , Turkey
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR