Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 6)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Vilaprisan (BAY1002670); Drug: Vilaprisan (BAY1002670); Drug: Vilaprisan (BAY1002670); Drug: Vilaprisan (BAY1002670); Drug: Vilaprisan (BAY1002670); Drug: Vilaprisan (BAY1002670); Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 1272
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China, 100010
    • Beijing Hospital of Traditional Chinese Medicine
  • Beijing, China, 100026
    • Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
  • Beijing, China, 100050
    • Beijing Tiantan Hospital, Captial Medical University
  • Beijing, China, 100730
    • Peking Union Medical College Hospital CAMS
  • Shanghai, China, 200030
    • International Peace Maternity&Child Health Hospital of CWI
  • Shanghai, China, 200433
    • Changhai Hospital of Second Military Medical University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300193
    • First Teaching Hosptial of Tianjin University of TCM
  • Tianjin, China, 300199
    • Tianjin Central Hospital of Gynecology obstetrics
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • 900TH Hospital of Joint Logistics Support Force
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
    • Guangzhou, Guangdong, China, 510405
      • The First Affiliated Hospital of Guangzhou University of TCM
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The 2nd Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China, 430013
      • Wuhan Tongji Reproductive Medicine Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Maternal and Child Health Hospital
    • Nanchang, Jiangxi, China, 330200
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun City, Jilin, China, 130061
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The first affiliated hospital of Dalian Medical University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The Second Affiliated Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Second University Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital School of Medicine Zhejiang University
    • Wenzhou, Zhejiang, China, 325000
      • The Second Affliated Hospital of Wenzhou Medicial University
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Hradec Kralove, Czechia, 50005
    • Fakultni Nemocnice Hradec Kralove
  • Jihlava, Czechia, 586 01
    • MUDr. Radek Fiker s.r.o.
  • Olomouc, Czechia, 772 00
    • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • Olomouc, Czechia, 77900
    • Fakultni Nemocnice Olomouc
  • Pisek, Czechia, 39701
    • Centrum gynekologicke rehabilitace
  • Tabor, Czechia, 39003
    • Dr. Smrhova-Kovacs
  • Vodnany, Czechia, 389 01
    • MUDr. Pavlina Nejedla s.r.o.
• Finland
  • Kuopio, Finland, 70100
    • Mehiläinen Kuopio
  • Oulu, Finland, 90100
    • Lääkärikeskus Gyneko
• Hong Kong
  • Hongkong, Hong Kong
    • Queen Mary Hospital
• Japan
  • Fukui, Japan, 910-0845
    • Kato Internal medicine and Gynecology Clinic
  • Fukuoka, Japan, 810-0062
    • Sano Women's Clinic
  • Kagoshima, Japan, 892-0826
    • Unoki Clinic
  • Osaka, Japan, 530-0013
    • Medical corporation keizukai Chayamachi Ladies Clinic
  • Osaka, Japan, 541-0048
    • Chayamachi ladies Clinic Hommachi
  • Osaka, Japan, 542-0076
    • Medical Corporation Koshinkai Nomura Clinic Namba
  • Osaka, Japan, 543-0023
    • Izuma Clinic
  • Shizuoka, Japan, 422-8527
    • Shizuoka Saiseikai General Hospital
  • Shizuoka, Japan, 424-8636
    • Shizuoka City Shimizu Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 460-0011
      • Kano's Clinic for Women
  • Chiba
    • Funabashi, Chiba, Japan, 274-0063
      • Kyoritsu Narashinodai Hospital
    • Matsudo, Chiba, Japan, 270-2267
      • Iryohojinshadan Seijunkai Juno Vesta Clinic Hatta
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8505
      • Aso Iizuka Hospital
  • Fukushima
    • Koriyama, Fukushima, Japan, 963-8585
      • Jusendo Geneal Hospital Yuasa Foundation
  • Gunma
    • Takasaki, Gunma, Japan, 370-0836
      • Sato Hospital
  • Hokkaido
    • Ebetsu, Hokkaido, Japan, 067-0031
      • Primo Women's Clinic
    • Sapporo, Hokkaido, Japan, 001-0013
      • Sapporo Maternity Women's Hospital
    • Sapporo, Hokkaido, Japan, 003-0005
      • Sapporo Shiroishi Obstetrics and Gynecology Hospital
    • Sapporo, Hokkaido, Japan, 004-0052
      • Hashimoto Clinic
    • Sapporo, Hokkaido, Japan, 060-0001
      • Ena Odori Clinic
    • Sapporo, Hokkaido, Japan, 060-0061
      • Sapporo Maternity Women's Minami1jo Clinic
    • Sapporo, Hokkaido, Japan, 060-0061
      • SAPPORO MEDICAL CENTER, NTT East Corporation
    • Sapporo, Hokkaido, Japan, 063-0061
      • Sapporo West Ladies Clinic
    • Sapporo, Hokkaido, Japan, 064-0808
      • Yoshio Clinic
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8530
      • Ishikawa Prefectural Central Hospital
  • Kagawa
    • Takamatsu, Kagawa, Japan, 760-0076
      • Asahi-Clinic
    • Takamatsu, Kagawa, Japan, 760-8557
      • Kagawa Prefectural Central Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 212-0021
      • Second Kawasaki Saiwai Clinic
  • Okayama
    • Kurashiki, Okayama, Japan, 710-0824
      • Kurashiki Medical Clinic
  • Osaka
    • Suita, Osaka, Japan, 564-0082
      • Suita Municipal Hospital
  • Saitama
    • Soka, Saitama, Japan, 340-0028
      • Medical Topia Soka Hospital
  • Shizuoka
    • Numazu, Shizuoka, Japan, 410-8555
      • Fuyo Association Seirei Numazu Hospital
  • Tokyo
    • Bunkyo, Tokyo, Japan, 112-0014
      • Sei Womens Clinic
    • Chuo-ku, Tokyo, Japan, 104-0061
      • Ginza Yoshida Clinic
    • Chuo-ku, Tokyo, Japan, 104-0061
      • Women's wellness Tsushima Ruriko josei life clinic Ginza
    • Chuoku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital
    • Fuchu, Tokyo, Japan, 183-0056
      • Akazawa Clinic
    • Hachioji, Tokyo, Japan, 192-0046
      • Medical Corp. SEIKOUKAI New Medical Research System Clinic
    • Minato, Tokyo, Japan, 105-0001
      • Toranomon Womens Clinic
    • Minato, Tokyo, Japan, 107-0051
      • Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
    • Minato, Tokyo, Japan, 108-0071
      • Shirokane Ladies' Clinic
    • Minato-ku, Tokyo, Japan, 108-0014
      • Yokokura Clinic
    • Setagaya-ku, Tokyo, Japan, 157-0061
      • Kugayama Hospital
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
    • Toshima-ku, Tokyo, Japan, 171-0021
      • Ikebukuro Metropolitan Clinic
• Mexico
  • Querétaro, Mexico, 76000
    • Sanatorio Alcocer Pozo S. A. de C. V.
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico
      • Hospital Universitario "José Eleuterio González"
  • Querétaro
    • San Juan del Río, Querétaro, Mexico, 76800
      • Centro Integral Médico de San Juan del Río S. C.
• Norway
  • Fredrikstad, Norway, 1605
    • Kirkeparken Spesialistpraksis
  • Nesttun, Norway, 5221
    • Nesttun Spesialistpraksis AS
  • Trondheim, Norway, 7014
    • Medicus AS
• Poland
  • Bialystok, Poland, 15-244
    • Prywatna Klinika Ginekologiczno-Poloznicza
  • Katowice, Poland, 40-156
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Katowice, Poland, 40-851
    • Gyncentrum Sp. z o.o.
  • Lodz, Poland, 90-602
    • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Lublin, Poland, 20-093
    • Centrum Medyczne Chodzki
  • Lublin, Poland, 20-400
    • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
• Russian Federation
  • Irkutsk, Russian Federation, 664003
    • Scientific Center of family health & human reprod. problems
  • Krasnodar, Russian Federation, 350012
    • Regional Clinical Hospital #2
  • Krasnoyarsk, Russian Federation, 660074
    • Krasnoyarsk regional perinatal center
  • Moscow, Russian Federation, 115280
    • City Clinical Hospital #13 Moscow
  • Moscow, Russian Federation, 117036
    • Endocrinology Research Center
  • Samara, Russian Federation, 443067
    • Close Joint Stock Company "Medical Company IDK"
  • St. Petersburg, Russian Federation, 197022
    • St. Petersburg Medical University n.a. I.P. Pavlov
  • St. Petersburg, Russian Federation, 198329
    • "Granti-Med"
  • St. Petersburg, Russian Federation, 199034
    • Scien. Res. Institute of Obsterics, Gyn. & Reproduction
• South Africa
  • Gauteng
    • Lyttelton Manor, Gauteng, South Africa, 0141
      • Dr L Reynders Practice
    • Pretoria, Gauteng, South Africa, 0002
      • University of Pretoria, Clinical Research Unit
  • Kwazulu-Natal
    • Umhlanga, Kwazulu-Natal, South Africa, 4321
      • Femway Inc
    • Wentworth, Kwazulu-Natal, South Africa, 4052
      • Durban International Clinical Research Site
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7405
      • Drs AEVITAS Clinic (Pty) Ltd
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town Clinical Research Centre
    • Panorama, Western Cape, South Africa, 7500
      • Clintrials Centre for Clinical Research
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol
• Turkey
  • Adana, Turkey, 01330
    • Cukurova Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 6100
    • Ankara Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey
    • Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
  • Bursa, Turkey, 16059
    • Uludag Universitesi Tip Fakultesi
  • Istanbul, Turkey, 34093
    • Istanbul Universitesi Istanbul Tip Fakultesi
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
    • Mobile, Alabama, United States, 36604
      • Women's Health Alliance of Mobile
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research - Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72204
      • Lynn Institute of the Ozarks
  • California
    • Encinitas, California, United States, 92024
      • Diagnamics, Inc.
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • San Diego, California, United States, 92111
      • Womens Health Care Research Corporation
    • San Diego, California, United States, 92120
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92123
      • West Coast OB/GYN Associates
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Advanced Women's Health Institute
    • Lakewood, Colorado, United States, 80228
      • Physicians Research Options, LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University School Of Medicine
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Office of Dr. James A. Simon, MD
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics, LLC
    • Clearwater, Florida, United States, 33759
      • Women's Medical Research Group, LLC
    • Doral, Florida, United States, 33166
      • Dr. Victoria Garcia & Associates, LLC Doral Medical Research
    • Fort Lauderdale, Florida, United States, 33316
      • M & O Clinical Research, LLC
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research, Inc.
    • Loxahatchee Groves, Florida, United States, 33470
      • Axcess Medical Research, LLC
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research Center, Inc.
    • Palm Harbor, Florida, United States, 34684
      • Suncoast Clinical Research
    • Saint Cloud, Florida, United States, 34769
      • ONCOVA Clinical Research, Inc.
    • Sarasota, Florida, United States, 34239
      • Swor Women's Care
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Research Institute, Inc. - Atlanta
    • Atlanta, Georgia, United States, 30364
      • Medisense Inc at Atlantic Station
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • College Park, Georgia, United States, 30349
      • Paramount Research Solutions-College Park
    • Savannah, Georgia, United States, 31406
      • Fellows Research Alliance - Savannah
    • Snellville, Georgia, United States, 30078
      • Journey Medical Research
  • Illinois
    • Palos Heights, Illinois, United States, 60463
      • Center For Women's Research
  • Kansas
    • Wichita, Kansas, United States, 67205-1138
      • Professional Research Network of Kansas, LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Praetorian Pharmaceutical Research, LLC
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates LLC
    • Shreveport, Louisiana, United States, 71118
      • Omni Fertility and Laser Institute
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University School of Medicine
    • Pikesville, Maryland, United States, 21208
      • Baltimore Suburban Health, LLC
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions, LLC
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48201
      • Wayne State University Physicians Group
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Wake Research - Clinical Research Center of Nevada, LLC
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB/GYN Associates
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Womens Care
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • Manhattan Medical Research
    • Staten Island, New York, United States, 10306
      • Richmond ObGyn Associates PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Healthcare System
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research & Wellness Center
    • Greensboro, North Carolina, United States, 27408
      • Unified Women's Clinical Research - Greensboro
    • Morehead City, North Carolina, United States, 28557
      • Unified Women's Clinical Research - Morehead City
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center
    • Raleigh, North Carolina, United States, 27607
      • Women's Health Alliance
    • Raleigh, North Carolina, United States, 27612
      • Wake Research, Inc.
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Valaoras & Lewis OB/GYN
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Clinical Inquest Center, Ltd.
    • Dayton, Ohio, United States, 45409-2793
      • Miami Valley Hospital
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Of Philadelphia, Llc
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29201
      • Vista Clinical Research
    • Greenville, South Carolina, United States, 29615
      • VitaLink Research - Greenville
    • Myrtle Beach, South Carolina, United States, 29572
      • Venus Gynecology, LLC former Magnolia OB/GYN Research Center
    • West Columbia, South Carolina, United States, 29169
      • Invocare Clinical Research Center, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Memphis, Tennessee, United States, 38104
      • Women's Physician Group
  • Texas
    • Dallas, Texas, United States, 75231
      • Discovery Clinical Trials - Dallas
    • Fort Worth, Texas, United States, 76104-4145
      • Signature GYN Services, Pllc
    • Fort Worth, Texas, United States, 76104
      • Office of Dr. Delbert Alan Johns, MD
    • Houston, Texas, United States, 77054
      • The Woman's Hospital of Texas
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77030
      • Advances in Health, Inc.
    • Irving, Texas, United States, 75062
      • MacArthur OB/GYN Mangement, LLC
    • Lampasas, Texas, United States, 76550
      • Family Medicine Clinic
    • Plano, Texas, United States, 75093
      • Willowbend Health and Wellness Associates
    • San Antonio, Texas, United States, 78229
      • Seven Oaks Women's Center
  • Virginia
    • Franklin, Virginia, United States, 23851
      • OB-GYN Physicians, Inc.
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women
    • North Chesterfield, Virginia, United States, 23235
      • Virginia Physicians For Women
    • Richmond, Virginia, United States, 23225
      • Clinical Trials of Viriginia
    • Richmond, Virginia, United States, 23226
      • Synexus Research, LLC
  • Washington
    • Tacoma, Washington, United States, 98402
      • MultiCare Health Systems Women's Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1(3/1 regimen); 2.0 mg treatment of 12 weeks, each separated by 1 bleeding break	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen); Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen); Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Experimental: A2(6/2 regimen); 2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen); Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen); Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Experimental: A3(3/2 regimen); 2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).; Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen); Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen); Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Other: B(Standard of care); Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment	Other: Standard of care; Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine	The 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.	From baseline to about 1 year after start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Bleeding Days	Number of bleeding days were defined 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 days	Treatment phase: approximately 1 year
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)	Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy	Up to 3 years (from study treatment start to end of study)
Change From Baseline in Endometrial Thickness	Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.	Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck	Percentage 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.	Treatment phase: approximately 1 year, follow-up phase: up to 2 years

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): May 10, 2019
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Uterine Fibroid
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: 16953; 2016-004822-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No