Trial Condition(s):
Uterine Fibroids
Assess safety and efficacy of Vilaprisan in subjects with uterine fibroids (ASTEROID 6)
Bayer Identifier:
16953
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lyndhurst Clinical Research Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women's Clinical Research - Morehead City Morehead City, United States, 28557 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Carolina Women's Research & Wellness Center Durham, United States, 27713 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Columbia University Medical Center New York, United States, 10032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Helix Biomedics, LLC Boynton Beach, United States, 33435 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Advances in Health, Inc. Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women’s Clinical Research - Greensboro Greensboro, United States, 27408 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HWC Women’s Research Center Englewood, United States, 45322 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Woman's Hospital of Texas Houston, United States, 77054 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center for Clinical Research San Diego, United States, 92120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centex Studies, Inc. Houston, United States, 77058 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Signature GYN Services, Pllc Fort Worth, United States, 76104-4145 | Status Completed | Contact Us: E-mail: clin[email protected] Phone: (+) 1-888-8422937 |
Locations Wake Research, Inc. Raleigh, United States, 27612 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Willowbend Health and Wellness Associates Plano, United States, 75093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Miami Valley Hospital Dayton, United States, 45409-2793 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tidewater Physicians for Women Norfolk, United States, 23502 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations OB-GYN Physicians, Inc. Franklin, United States, 23851 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fellows Research Alliance - Savannah Savannah, United States, 31406 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Southern Clinical Research Associates LLC Metairie, United States, 70001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations PMG Research of Wilmington Wilmington, United States, 28401 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Carolinas Healthcare System Charlotte, United States, 28204 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Advanced Women's Health Institute Greenwood Village, United States, 80111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seven Oaks Women’s Center San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Arkansas for Medical Sciences Little Rock, United States, 72205 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Paramount Research Solutions-College Park College Park, United States, 30349 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physicians Research Options, LLC Lakewood, United States, 80228 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Research - Clinical Research Center of Nevada, LLC Las Vegas, United States, 89123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Johns Hopkins University School of Medicine Baltimore, United States, 21205 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Solutions Through Advanced Research, Inc. Jacksonville, United States, 32256 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Atlanta Women's Research Institute, Inc. - Atlanta Atlanta, United States, 30342 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Richmond ObGyn Associates PC Staten Island, United States, 10306 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Augusta University Medical Center Augusta, United States, 30912 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medisense Inc at Atlantic Station Atlanta, United States, 30364 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Suncoast Clinical Research Palm Harbor, United States, 34684 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Professional Research Network of Kansas, LLC Wichita, United States, 67205-1138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations West Coast OB/GYN Associates San Diego, United States, 92123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peking Union Medical College Hospital CAMS Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni. Beijing, China, 100026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Dalian Medical University Dalian, China, 116011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Hospital of Traditional Chinese Medicine Beijing, China, 100010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Hospital of Jilin University Changchun, China, 130000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tianjin Central Hospital of Gynecology obstetrics Tianjin, China, 300199 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Discovery Clinical Trials - Dallas Dallas, United States, 75231 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Coastal Clinical Research, Inc Mobile, United States, 36608 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations M & O Clinical Research, LLC Ft. Lauderdale, United States, 33316 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Virginia Physicians For Women North Chesterfield, United States, 23235 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lawrence OB/GYN Associates Lawrenceville, United States, 08648 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Trials of Viriginia Richmond, United States, 23225 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Journey Medical Research Snellville, United States, 30078 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oregon Health and Science University Portland, United States, 97239 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wayne State University Physicians Group Detroit, United States, 48201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Agile Clinical Research Trials, LLC Atlanta, United States, 30328 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bosque Womens Care Albuquerque, United States, 87109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Axcess Medical Research, LLC Loxahatchee, United States, 33470 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Stamford Hospital Stamford, United States, 06904 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Office of Dr. Delbert Alan Johns, MD Fort Worth, United States, 76104 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Suncoast Clinical Research Center, Inc. New Port Richey, United States, 34652 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yale University School of Medicine New Haven, United States, 06511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lynn Institute of the Ozarks Little Rock, United States, 72204 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Swor Women's Care Sarasota, United States, 34239 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SUNY Downstate Medical Center Brooklyn, United States, 11203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Center For Women's Research Palos Heights, United States, 60463 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Continental Clinical Solutions, LLC Towson, United States, 21204 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Diagnamics, Inc. Encinitas, United States, 92024 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vista Clinical Research Columbia, United States, 29201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The 2nd Hospital of Hebei Medical University Shijiazhuang, China, 050000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Alliance Raleigh, United States, 27607 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MultiCare Health Systems Women's Health Care Tacoma, United States, 98402 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Omni Fertility and Laser Institute Shreveport, United States, 71118 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Office of Dr. James A. Simon, MD Washington, United States, 20036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Penn State Milton S. Hershey Medical Center Hershey, United States, 17033-0850 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Drexel University College of Medicine Philadelphia, United States, 19102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital of the University of Pennsylvania Philadelpahia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Valaoras & Lewis OB/GYN Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Research Integrity, LLC Owensboro, United States, 42303 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Central Research Associates, Inc. Birmingham, United States, 35205 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ClinSearch, LLC Chattanooga, United States, 37421 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Physician Group Memphis, United States, 38104 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations VitaLink Research - Greenville Greenville, United States, 29615 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MacArthur OB/GYN Mangement, LLC Irving, United States, 75062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Grossmont Center for Clinical Research La Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Venus Gynecology, LLC former Magnolia OB/GYN Research Center Myrtle Beach, United States, 29572 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Baltimore Suburban Health, LLC Pikesville, United States, 21208 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical University of South Carolina Charleston, United States, 29425 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Synexus Research, LLC Richmond, United States, 23226 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Invocare Clinical Research Center, LLC West Columbia, United States, 29169 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ONCOVA Clinical Research, Inc. Saint Cloud, United States, 34769 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Family Medicine Clinic Lampasas, United States, 76550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Womens Health Care Research Corporation San Diego, United States, 92111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Manhattan Medical Research New York, United States, 10016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eastern Carolina Women's Center New Bern, United States, 28562 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jersey Shore University Medical Center Neptune, United States, 07753 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Scien. Res. Institute of Obsterics, Gyn. & Reproduction St. Petersburg, Russia, 199034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations "Granti-Med" St. Petersburg, Russia, 198329 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Petersburg Medical University n.a. I.P. Pavlov St. Petersburg, Russia, 197022 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations City Clinical Hospital #13 Moscow Moscow, Russia, 115280 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Close Joint Stock Company "Medical Company IDK" Samara, Russia, 443067 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Regional Clinical Hospital #2 Krasnodar, Russia, 350012 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Endocrinology Research Center Moscow, Russia, 117036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krasnoyarsk regional perinatal center Krasnoyarsk, Russia, 660074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Scientific Center of family health & human reprod. problems Irkutsk, Russia, 664003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peking University First Hospital Beijing, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV. Guangzhou, China, 510120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wuhan Tongji Reproductive Medicine Hospital Wuhan, China, 430013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations First Teaching Hosptial of Tianjin University of TCM Tianjin, China, 300193 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tianjin Medical University General Hospital Tianjin, China, 300052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centrum gynekologicke rehabilitace Pisek, Czech Republic, 39701 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc, Czech Republic, 772 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 50005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 77900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Inquest Center, Ltd. Beavercreek, United States, 45432 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praetorian Pharmaceutical Research, LLC Marrero, United States, 70072 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Alliance of Mobile Mobile, United States, 36604 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kagawa Prefectural Central Hospital Takamatsu, Japan, 760-8557 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ginza Yoshida Clinic Chuo-ku, Japan, 104-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mehiläinen Kuopio Kuopio, Finland, 70100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lääkärikeskus Gyneko Oulu, Finland, 90100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr. Victoria Garcia & Associates, LLC Doral Medical Research Doral, United States, 33166 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hashimoto Clinic Sapporo, Japan, 004-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yoshio Clinic Sapporo, Japan, 064-0808 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iryohojinshadan Seijunkai Juno Vesta Clinic Hatta Matsudo, Japan, 270-2267 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical corporation keizukai Chayamachi Ladies Clinic Osaka, Japan, 530-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kurashiki Medical Clinic Kurashiki, Japan, 710-0824 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Aso Iizuka Hospital Iizuka, Japan, 820-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Corporation Koshinkai Nomura Clinic Namba Osaka, Japan, 542-0076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Topia Soka Hospital Soka, Japan, 340-0028 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SAPPORO MEDICAL CENTER, NTT East Corporation Sapporo, Japan, 060-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ishikawa Prefectural Central Hospital Kanazawa, Japan, 920-8530 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Second Kawasaki Saiwai Clinic Kawasaki, Japan, 212-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sapporo Shiroishi Obstetrics and Gynecology Hospital Sapporo, Japan, 003-0005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sapporo West Ladies Clinic Sapporo, Japan, 063-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chayamachi ladies Clinic Hommachi Osaka, Japan, 541-0048 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ena Odori Clinic Sapporo, Japan, 060-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sei Womens Clinic Bunkyo, Japan, 112-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Suita Municipal Hospital Suita, Japan, 564-0082 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Corp. Seikoukai New Medical Research System Clinic Hachioji, Japan, 192-0046 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ikebukuro Metropolitan Clinic Toshima-ku, Japan, 171-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shirokane Ladies' Clinic Minato, Japan, 108-0071 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yokokura Clinic Minato-ku, Japan, 108-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's wellness Tsushima Ruriko josei life clinic Ginza Chuo-ku, Japan, 104-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fuyo Association Seirei Numazu Hospital Numazu, Japan, 410-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St.Luke's International Hospital Chuoku, Japan, 104-8560 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kato Internal medicine and Gynecology Clinic Fukui, Japan, 910-0845 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sato Hospital Takasaki, Japan, 370-0836 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kugayama Hospital Setagaya-ku, Japan, 157-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sano Women's Clinic Fukuoka, Japan, 810-0062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IZUMA CLINIC Osaka, Japan, 543-0023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kano's Clinic for Women Nagoya, Japan, 460-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toranomon Womens Clinic Minato, Japan, 105-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic Minato, Japan, 107-0051 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jusendo Geneal Hospital Yuasa Foundation Koriyama, Japan, 963-8585 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Akazawa Clinic Fuchu, Japan, 183-0056 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations International Peace Maternity&Child Health Hospital of CWI Shanghai, China, 200030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations West China Second University Hospital Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Beijing Tiantan Hospital, Captial Medical University Beijing, China, 100050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shandong Provincial Hospital Jinan, China, 250021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affiliated Hospital of Shanxi Medical University Taiyuan, China, 030001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Xinjiang Medical University Urumqi, China, 830054 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nesttun Spesialistpraksis AS Nesttun, Norway, 5221 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kirkeparken Spesialistpraksis Fredrikstad, Norway, 1605 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medicus AS Trondheim, Norway, 7014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Hospital School of Medicine Zhejiang University Hangzhou, China, 310006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The People's Hospital of Guangxi Zhuang Autonomous Region Nanning, China, 530021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Prywatna Klinika Ginekologiczno-Poloznicza Bialystok, Poland, 15-244 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centrum Medyczne Chodzki Lublin, Poland, 20-093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz, Poland, 90-602 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin, Poland, 20-400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gyncentrum Sp. z o.o. Katowice, Poland, 40-851 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Zhongda Hospital Southeast University Nanjing, China, 210009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Queen Mary Hospital Hongkong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sanatorio Alcocer Pozo S. A. de C. V. Querétaro, Mexico, 76000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro Integral Médico de San Juan del Río S. C. San Juan del Río, Mexico, 76800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr L Reynders Practice Lyttelton Manor, South Africa, 0141 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clintrials Centre for Clinical Research Panorama, South Africa, 7500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nanjing Maternity and Child Health Care Hospital Nanjing, China, 210004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing, China, 210008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shizuoka Saiseikai General Hospital Shizuoka, Japan, 422-8527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unoki Clinic Kagoshima, Japan, 892-0826 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Changhai Hospital of Second Military Medical University Shanghai, China, 200433 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The First Affiliated Hospital of Guangzhou University of TCM Guangzhou, China, 510405 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affliated Hospital of Wenzhou Medicial University Wenzhou, China, 325000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Second Affiliated Hospital of Nanchang University Nanchang, China, 330006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 900th Hospital of Joint Logistics Support Force Fuzhou, China, 350025 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hainan General Hospital Haikou, China, 570311 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Third Affiliated Hospital, Sun Yat-Sen University Guangzhou, China, 510630 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peking University Shenzhen Hospital Shenzhen, China, 518036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sapporo Maternity Women's Minami1jo Clinic Sapporo, Japan, 060-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Primo Women's Clinic Ebetsu, Japan, 067-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sapporo Maternity Women's Hospital Sapporo, Japan, 001-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyoritsu Narashinodai Hospital Funabashi, Japan, 274-0063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shizuoka City Shimizu Hospital Shizuoka, Japan, 424-8636 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asahi-Clinic Takamatsu, Japan, 760-0076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uludag Universitesi Tip Fakultesi Bursa, Turkey, 16059 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ankara Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 6100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast Ankara, Turkey | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cukurova Universitesi Tip Fakultesi Hastanesi Adana, Turkey, 01330 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Femway Inc Umhlanga, South Africa, 4321 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Durban International Clinical Research Site Wentworth, South Africa, 4052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Drs AEVITAS Clinic (Pty) Ltd Cape Town, South Africa, 7405 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Pretoria, Clinical Research Unit Pretoria, South Africa, 0002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Cape Town Clinical Research Centre Cape Town, South Africa, 7925 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations King Chulalongkorn Memorial Hospital Bangkok, Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario "José Eleuterio González" Monterrey, Mexico | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Henry Ford Health System Detroit, United States, 48202 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MUDr. Pavlina Nejedla s.r.o. Vodnany, Czech Republic, 389 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jiangxi Maternal and Child Health Hospital Nanchang, China, 330006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MUDr. Radek Fiker s.r.o. Jihlava, Czech Republic, 586 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Percentage change in bone mineral density (BMD) of lumbar spineThe percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.Timeframe: From baseline to about 1 year after start of treatment
Secondary Outcome
- Number of bleeding daysNumber of bleeding days from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 daysTimeframe: Approximately 1 year
- Endometrial histologyNumber of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancyTimeframe: Approximately 1 year
- Endometrial thicknessUltrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.Timeframe: Approximately 1 year
- Percentage change from baseline in BMD measured at lumbar spine (other time points not mentioned as primary safety variable) and hip/femoral neckPercentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.Timeframe: Approximately 1 year on treatment and 1 year post treatment
Additional Information
Copyright © Bayer
Powered by
