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Brief Title: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
Official Title: A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study ID: NCT03400943
Brief Summary: The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
California Center for Clinical Research, Arcadia, California, United States
Core Healthcare Group, Cerritos, California, United States
AVIVA Research, Escondido, California, United States
National Research Institute - Los Angeles, Los Angeles, California, United States
Harbor - UCLA Medical Center, Torrance, California, United States
Ideal Clinical Research, Aventura, Florida, United States
South Florida Medical Research, Aventura, Florida, United States
Helix Biomedics, LLC, Boynton Beach, Florida, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research, Doral, Florida, United States
Sweet Hope Research Specialty, Inc. - Hialeah, Hialeah, Florida, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare, Jacksonville, Florida, United States
Altus Research, Lake Worth, Florida, United States
Axcess Medical Research, LLC, Loxahatchee Groves, Florida, United States
Ocean Blue Medical Research Center, Inc., Miami Springs, Florida, United States
Accelerated Enrollment Solutions a business of PPD, Orlando, Florida, United States
Discovery Clinical Research, Plantation, Florida, United States
ONCOVA Clinical Research, Inc., Saint Cloud, Florida, United States
Georgia Center For Women, Atlanta, Georgia, United States
Agile Clinical Research Trials, LLC, Atlanta, Georgia, United States
Atlanta Women's Research Institute, Inc. - Alpharetta, Atlanta, Georgia, United States
Medisense, Inc., Atlanta, Georgia, United States
Paramount Research Solutions-College Park, College Park, Georgia, United States
One Health Research Clinic, Norcross, Georgia, United States
Fellows Research Alliance - Savannah, Savannah, Georgia, United States
GTC Research, Shawnee Mission, Kansas, United States
Omni Fertility and Laser Institute, Shreveport, Louisiana, United States
PharmaSite Research, Inc., Baltimore, Maryland, United States
Simmonds, Martin and Helmbrecht, Gaithersburg, Maryland, United States
Advantia Health, LLC Obstetrics & Gynecology Assoc., Silver Spring, Maryland, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Carolinas Healthcare System, Charlotte, 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
Wake Research, Inc., Raleigh, North Carolina, United States
Main Line Fertility Center, Bryn Mawr, Pennsylvania, United States
Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, United States
Fellows Research Alliance, Inc., Bluffton, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Fusion Clinical Research of Spartanburg, LLC, Spartanburg, South Carolina, United States
Chattanooga Medical Research, LLC, Chattanooga, Tennessee, United States
Clinical Neurosciences Solutions, Inc DBA CNS Healthcare, Memphis, Tennessee, United States
Paramount Research Solutions-Nashville, Nashville, Tennessee, United States
Texas Health Care, PLLC, Fort Worth, Texas, United States
Willowbend Health & Wellness Associates, Frisco, Texas, United States
Family Medicine Clinic, Georgetown, Texas, United States
Biopharma Informatic, Inc., Houston, Texas, United States
Centex Studies, Inc., Houston, Texas, United States
The Center for Clinical Trials, Inc., Houston, Texas, United States
Houston Center for Clinical Research, LLC, Sugar Land, Texas, United States
Millennium Clinical Trials, LLC, Arlington, Virginia, United States
Synexus Research, LLC, Richmond, Virginia, United States
Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD, Gabrovo, , Bulgaria
Hospital for Active Treatment - Prof.Paraskev Stoyanov AD, Lovech, , Bulgaria
MHAT Dr. Bratan Shukerov AD, Smolyan, , Bulgaria
MHAT for Women's Health - Nadezhda OOD, Sofia, , Bulgaria
900th Hospital of Joint Logistics Support Force, Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Boai Hospital of Zhongshan, Zhongshan, Guangdong, China
Hainan General Hospital, Haikou, Hainan, 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
1st Affiliated hospital of Soochow University, Suzhou, 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, Jilin, China
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China
Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Med, Hangzhou, Zhejiang, China
The Second Affliated Hospital of Wenzhou Medicial University, Wenzhou, Zhejiang, China
Beijing Hospital of Traditional Chinese Medicine, Beijing, , China
Peking University First Hospital, Beijing, , China
Beijing Friendship Hospital, Capital Medical University, Beijing, , China
Beijing Tiantan Hospital, Captial Medical University, Beijing, , China
Shanghai East Hospital Affiated to Tongji University, Shanghai, , China
Tianjin Medical University General Hospital, Tianjin, , China
Gynekologie MEDA s.r.o., Brno, , Czechia
Soukroma gynekologicka ambulance, Fulnek, , Czechia
Gynekologie Studentsky dum s.r.o., Praha 6, , Czechia
MUDr. Ivana Salamonova s.r.o., Vysoke Myto, , Czechia
Clalit Health Services through HaEmek Medical Center, Afula, , Israel
Hillel Yaffe Medical Center, Hadera, , Israel
Lady Davis Carmel Medical Center, Haifa, , Israel
Meir Medical Center, Kfar Saba, , Israel
University Hospital Kebangsaan Malaysia, Kuala Lumpur, , Malaysia
Hospital Wanita dan Kanak-Kanak Sabah, Sabah, , Malaysia
Sarawak General Hospital, Sarawak, , Malaysia
P3 Research Ltd Hawkes Bay, Hawkes Bay, , New Zealand
P3 Research, Tauranga, , New Zealand
KK Women's and Children's Hospital, Singapore, , Singapore
Dr L Reynders Practice, Lyttelton Manor, Gauteng, South Africa
Wilgeheuwel Hospital, Roodepoort, Gauteng, South Africa
Umhlanga Medical Centre, Durban, Kwazulu-Natal, South Africa
Ethekwini Hospital & Heart Centre, Durban, Kwazulu-Natal, South Africa
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR