Spots Global Cancer Trial Database for Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
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Trial Identification
Brief Title: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
Official Title: A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study ID: NCT03400956
Conditions
Study Description
Brief Summary: The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Clearview Medical Research, LLC, Canyon Country, California, United States
Diagnamics, Inc., Encinitas, California, United States
National Research Institute, Huntington Park, California, United States
Grossmont Center for Clinical Research, La Mesa, California, United States
West Coast OB/GYN Associates, La Mesa, California, United States
National Research Institute, Panorama City, California, United States
Artemis Institute for Clinical Research, San Diego, California, United States
Medical Center for Clinical Research, San Diego, California, United States
Women's Medical Research Group, LLC, Clearwater, Florida, United States
Vital Pharma Research, Hialeah, Florida, United States
Solutions Through Advanced Research, Inc., Jacksonville, Florida, United States
Health Awareness, Inc., Jupiter, Florida, United States
South Florida Clinical Research Institute, Margate, Florida, United States
Savin Medical Group LLC, Miami Lakes, Florida, United States
Suncoast Research Group, LLC, Miami, Florida, United States
Advanced Pharma CR, LLC, Miami, Florida, United States
Genoma Research Group, Inc., Miami, Florida, United States
Florida Research Center, Inc., Miami, Florida, United States
Miami Dade Medical Research Institute, LLC, Miami, Florida, United States
Vista Health Research, Miami, Florida, United States
Palmetto Professional Research, Miami, Florida, United States
A Premier Medical Research of Florida, LLC, Orange City, Florida, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare, Orlando, Florida, United States
Oviedo Medical Research, LLC, Oviedo, Florida, United States
DMI Research, Pinellas Park, Florida, United States
Physician Care Clinical Research, Sarasota, Florida, United States
Journey Medical Research, Snellville, Georgia, United States
Women's Healthcare Associates, PA, Idaho Falls, Idaho, United States
New England Center for Clinical Research, Inc., Fall River, Massachusetts, United States
Altea Research Institute, Las Vegas, Nevada, United States
Unified Women's Clinical Research, Greensboro, North Carolina, United States
PMG Research of Wilmington, Wilmington, North Carolina, United States
Unified Women's Clinical Research / Ocala, FL, Winston-Salem, North Carolina, United States
Oregon Health and Science University, Portland, Oregon, United States
The Clinical Trial Center, LLC, Jenkintown, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Vista Clinical Research, Columbia, South Carolina, United States
Chattanooga Women for Women, Hixson, Tennessee, United States
Women Partners in Health Obstetrics & Gynecology (OB/GYN), Austin, Texas, United States
Gadolin Research, Beaumont, Texas, United States
Discovery Clinical Trials, Dallas, Texas, United States
Advances in Health, Inc., Houston, Texas, United States
Discovery Clinical Trials, San Antonio, Texas, United States
Center of Reproductive Medicine, Webster, Texas, United States
Tidewater Physicians for Women, Norfolk, Virginia, United States
Seattle Clinical Research Center, Seattle, Washington, United States
GynPorCentrum s.r.o., Krnov, , Czechia
Gynekologie MUDr. Jaromir Karban s.r.o, Neratovice, , Czechia
Privatni gynekologicko-porodnicka ordinace, Praha, , Czechia
GYNEVI s.r.o., Rokycany, , Czechia
Gynekologicka ambulance - Zabreh na Morave, Zabreh Na Morave, , Czechia
Funabashi Municipal Medical Center, Funabashi, Chiba, Japan
Tsujinaka Hospital Kashiwanoha, Kashiwa, Chiba, Japan
Matsudo City General Hospital, Matsudo, Chiba, Japan
Hashimoto Clinic, Sapporo, Hokkaido, Japan
Ena Odori Clinic, Sapporo, Hokkaido, Japan
Tokeidai Memorial Clinic, Sapporo, Hokkaido, Japan
Yoshio Clinic, Sapporo, Hokkaido, Japan
Kosumo Clinic, Kako-gun, Hyogo, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Takamatsu Red Cross Hospital, Takamatsu, Kagawa, Japan
Asahi-Clinic., Takamatsu, Kagawa, Japan
Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan
Shonan Fujisawa Tokushukai Hospital, Fujisawa, Kanagawa, Japan
Kyoto city Hospital, Nakagyo-ku, Kyoto, Japan
Medical Topia Soka Hospital, Soka, Saitama, Japan
Omi Medical Center, Kusatsu, Shiga, Japan
Saiseikai Fukuoka General Hospital, Fukuoka, , Japan
Unoki Clinic, Kagoshima, , Japan
Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine, Kagoshima, , Japan
Four Seasons Ladies' Clinic, Kumamoto, , Japan
Japanese Red Cross Kumamoto Hospital, Kumamoto, , Japan
Ijinkai Takeda General Hospital, Kyoto, , Japan
Japanese Red Cross Kyoto Daini Hospital, Kyoto, , Japan
Gokeikai Osaka Kaisei Hospital, Osaka, , Japan
Osaka City Hospital Organization Osaka City General Hospital, Osaka, , Japan
Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi, Osaka, , Japan
Altai State Medical University, Barnaul, , Russian Federation
Maternity Hospital, 17, Saint-Petersburg, , Russian Federation
Close Joint Stock Company "Medical Company IDK", Samara, , Russian Federation
Smolensk State Medical University, Smolensk, , Russian Federation
Med Estetic Center, St. Petersburg, , Russian Federation
"Granti-Med", St. Petersburg, , Russian Federation
Scien. Res. Institute of Obsterics, Gyn. & Reproduction, St. Petersburg, , Russian Federation
Chernivtsi Regional Perinatal Center, Chernivtsi, , Ukraine
Vinnytsia City Clinical Maternity Hospital No 2, Vinnytsia, , Ukraine
Zaporizhzhia Regional Clinical Hospital, Zaporizhzhya, , Ukraine
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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