Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
- Conditions
- Uterine Fibroids
- Interventions
- Other: Standard of careDrug: Vilaprisan (BAY1002670)
- Registration Number
- NCT03194646
- Lead Sponsor
- Bayer
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 1272
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B(Standard of care) Standard of care Standard of care as determined by the investigators, this could be watch \& wait or non-hormonal medical treatment A1(3/1 regimen) Vilaprisan (BAY1002670) 2.0 mg treatment of 12 weeks, each separated by 1 bleeding break A2(6/2 regimen) Vilaprisan (BAY1002670) 2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break A3(3/2 regimen) Vilaprisan (BAY1002670) 2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
- Primary Outcome Measures
Name Time Method Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine From baseline to about 1 year after start of treatment 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.
- Secondary Outcome Measures
Name Time Method Number of Bleeding Days Treatment phase: approximately 1 year 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
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis) Up to 3 years (from study treatment start to end of study) Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy
Change From Baseline in Endometrial Thickness Treatment phase: approximately 1 year, follow-up phase: up to 2 years 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.
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck Treatment phase: approximately 1 year, follow-up phase: up to 2 years 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.
Trial Locations
- Locations (219)
Baltimore Suburban Health, LLC
🇺🇸Pikesville, Maryland, United States
Advances in Health, INC. | Houston, TX
🇺🇸Houston, Texas, United States
Coastal Clinical Research, Inc
🇺🇸Mobile, Alabama, United States
Atlanta Women's Research Institute, Inc. - Atlanta
🇺🇸Atlanta, Georgia, United States
Visions Clinical Research - Tucson
🇺🇸Tucson, Arizona, United States
Swor Women's Care
🇺🇸Sarasota, Florida, United States
Women's Health Alliance of Mobile
🇺🇸Mobile, Alabama, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Diagnamics | Encinitas, CA
🇺🇸Encinitas, California, United States
Center For Women's Research
🇺🇸Palos Heights, Illinois, United States
Suncoast Clinical Research Inc | Pinellas
🇺🇸Palm Harbor, Florida, United States
M & O Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Medisense Inc at Atlantic Station
🇺🇸Atlanta, Georgia, United States
Lynn Health Science Institute | Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Physicians' Research Options, LLC | Red Rocks OBGYN
🇺🇸Lakewood, Colorado, United States
Bosque Women's Care | Albuquerque, NM
🇺🇸Albuquerque, New Mexico, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
Manhattan Medical Research
🇺🇸New York, New York, United States
Southern Clinical Research Associates | Metairie, LA
🇺🇸Metairie, Louisiana, United States
ONCOVA Clinical Research, Inc.
🇺🇸Saint Cloud, Florida, United States
Helix Biomedics LLC | Boynton Beach, FL
🇺🇸Boynton Beach, Florida, United States
Praetorian Pharmaceutical Research, LLC
🇺🇸Marrero, Louisiana, United States
Capital Health | Capital Health OBGYN Lawrenceville
🇺🇸Lawrenceville, New Jersey, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
🇺🇸Doral, Florida, United States
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China
Richmond ObGyn Associates PC
🇺🇸Staten Island, New York, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Omni Fertility and Laser Institute
🇺🇸Shreveport, Louisiana, United States
Office of Dr. Delbert Alan Johns, MD
🇺🇸Fort Worth, Texas, United States
Continental Clinical Solutions | Towson, MD
🇺🇸Towson, Maryland, United States
Venus Gynecology, LLC | Myrtle Beach, SC
🇺🇸Myrtle Beach, South Carolina, United States
The Woman's Hospital of Texas
🇺🇸Houston, Texas, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX
🇺🇸Fort Worth, Texas, United States
Willowbend Health and Wellness Associates
🇺🇸Plano, Texas, United States
Centex Studies, Inc.
🇺🇸Lake Charles, Louisiana, United States
Invocare Clinical Research Center, LLC
🇺🇸West Columbia, South Carolina, United States
Women's Clinic of Lincoln, P.C. | Lincoln, NE
🇺🇸Lincoln, Nebraska, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
Tidewater Clinical Research | Virginia Beach, VA
🇺🇸Norfolk, Virginia, United States
900th Hospital of Joint Logistics Support Force
🇨🇳Fuzhou, Fujian, China
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Family Medicine Clinic
🇺🇸Georgetown, Texas, United States
MultiCare Health Systems Women's Health Care
🇺🇸Covington, Washington, United States
ClinSearch, LLC
🇺🇸Hixson, Tennessee, United States
Discovery Clinical Trials - Dallas
🇺🇸Dallas, Texas, United States
Clinical Research Philadelphia | Philadelphia, PA
🇺🇸Philadelphia, Pennsylvania, United States
OB-GYN Physicians, Inc.
🇺🇸Franklin, Virginia, United States
Unified Women's Clinical Research
🇺🇸Greensboro, North Carolina, United States
Clinical Inquest Center, Ltd.
🇺🇸Beavercreek, Ohio, United States
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
🇨🇳Guangzhou, Guangdong, China
MacArthur OB/GYN Mangement, LLC
🇺🇸Irving, Texas, United States
Centrum gynekologicke rehabilitace
🇨🇿Písek, Jihoceský Kraj, Czechia
HWC Women's Research Center | Englewood, OH
🇺🇸Englewood, Ohio, United States
Virginia Physicians For Women
🇺🇸North Chesterfield, Virginia, United States
Vista Clinical Research
🇺🇸Columbia, South Carolina, United States
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
MUDr. Radek Fiker s.r.o.
🇨🇿Jihlava, Czechia
Asahi-Clinic
🇯🇵Takamatsu, Kagawa, Japan
Kyoritsu Narashinodai Hospital
🇯🇵Funabashi, Chiba, Japan
G-Centrum Olomouc s.r.o. Dr. Skrivanek
🇨🇿Ceske Budejovice, Czechia
Jusendo Geneal Hospital Yuasa Foundation
🇯🇵Koriyama, Fukushima, Japan
Ena Odori Clinic
🇯🇵Sapporo, Hokkaido, Japan
SAPPORO MEDICAL CENTER, NTT East Corporation
🇯🇵Sapporo, Hokkaido, Japan
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Fakultni Nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Sapporo Maternity Women's Hospital
🇯🇵Sapporo, Hokkaido, Japan
Yoshio Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kano's Clinic for Women
🇯🇵Nagoya, Aichi, Japan
Juno Vesta Clinic Hatta
🇯🇵Matsudo, Chiba, Japan
Sapporo West Ladies Clinic
🇯🇵Sapporo, Hokkaido, Japan
MUDr. Pavlina Nejedla s.r.o.
🇨🇿Vodnany, Czechia
Medical corporation keizukai Chayamachi Ladies Clinic
🇯🇵Osaka, Japan
Scientific Center of family health & human reprod. problems
🇷🇺Irkutsk, Russian Federation
Fakultni Nemocnice Olomouc
🇨🇿Olomouc, Czechia
Sato Hospital
🇯🇵Takasaki, Gunma, Japan
Ginza Yoshida Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Endocrinology Research Center
🇷🇺Moscow, Russian Federation
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Kagawa, Japan
Suita Municipal Hospital
🇯🇵Suita, Osaka, Japan
Second Kawasaki Saiwai Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Gyncentrum Sp. z o.o.
🇵🇱Katowice, Poland
University of Pretoria, Clinical Research Unit
🇿🇦Pretoria, Gauteng, South Africa
"Granti-Med"
🇷🇺St. Petersburg, Russian Federation
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
🇹🇷Ankara, Turkey
Regional Clinical Hospital #2
🇷🇺Krasnodar, Russian Federation
Izuma Clinic
🇯🇵Osaka, Japan
CLINICAL MEDICAL RESEARCH Sp. z o. o.
🇵🇱Katowice, Poland
Krasnoyarsk regional perinatal center
🇷🇺Krasnoyarsk, Russian Federation
Cukurova Universitesi Tip Fakultesi Hastanesi
🇹🇷Adana, Turkey
Medical Corporation Koshinkai Nomura Clinic Namba
🇯🇵Osaka, Japan
Shizuoka City Shimizu Hospital
🇯🇵Shizuoka, Japan
Sanatorio Alcocer Pozo S. A. de C. V.
🇲🇽Querétaro, Mexico
Kirkeparken Spesialistpraksis
🇳🇴Fredrikstad, Norway
Shizuoka Saiseikai General Hospital
🇯🇵Shizuoka, Japan
Uludag Universitesi Tip Fakultesi
🇹🇷Bursa, Turkey
Dr L Reynders Practice
🇿🇦Lyttelton Manor, Gauteng, South Africa
City Clinical Hospital #13 Moscow
🇷🇺Moscow, Russian Federation
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Close Joint Stock Company "Medical Company IDK"
🇷🇺Samara, Russian Federation
St. Petersburg Medical University n.a. I.P. Pavlov
🇷🇺St. Petersburg, Russian Federation
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
🇷🇺St. Petersburg, Russian Federation
Ankara Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi
🇹🇷Istanbul, Turkey
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
West Coast OB/GYN Associates
🇺🇸San Diego, California, United States
M3 Wake Research | Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Carolina Women's Research & Wellness Center
🇺🇸Durham, North Carolina, United States
Seven Oaks Women's Center
🇺🇸San Antonio, Texas, United States
Durban International Clinical Research Site
🇿🇦Wentworth, Kwazulu-Natal, South Africa
Femway Inc
🇿🇦Umhlanga, Kwazulu-Natal, South Africa
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The First Affiliated Hospital of Guangzhou University of TCM
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Wuhan Tongji Reproductive Medicine Hospital
🇨🇳Wuhan, Hubei, China
Nanjing Maternity and Child Health Care Hospital
🇨🇳Nanjing, Jiangsu, 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
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, China
Beijing Tiantan Hospital, Captial Medical University
🇨🇳Beijing, China
Peking Union Medical College Hospital CAMS
🇨🇳Beijing, China
International Peace Maternity&Child Health Hospital of CWI
🇨🇳Shanghai, China
Changhai Hospital of Second Military Medical University
🇨🇳Shanghai, China
First Teaching Hosptial of Tianjin University of TCM
🇨🇳Tianjin, China
Tianjin Central Hospital of Gynecology obstetrics
🇨🇳Tianjin, China
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland
🇫🇮Oulu, Finland
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Mehilainen | Mehilainen Kuopio
🇫🇮Kuopio, Finland
Akazawa Clinic
🇯🇵Fuchu, Tokyo, Japan
Toranomon Womens Clinic
🇯🇵Minato, Tokyo, Japan
Siriraj Hospital, Mahidol
🇹🇭Bangkok, Thailand
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
🇵🇱Lodz, Poland
Ikebukuro Metropolitan Clinic
🇯🇵Toshima-ku, Tokyo, Japan
Shirokane Ladies' Clinic
🇯🇵Minato, Tokyo, Japan
Drs AEVITAS Clinic (Pty) Ltd
🇿🇦Cape Town, Western Cape, South Africa
Kugayama Hospital
🇯🇵Setagaya-ku, Tokyo, Japan
Medical Corp. Seikoukai New Medical Research System Clinic
🇯🇵Hachioji, Tokyo, Japan
Hospital Universitario "José Eleuterio González"
🇲🇽Monterrey, Nuevo Leon, Mexico
Nesttun Spesialistpraksis AS
🇳🇴Nesttun, Norway
Prywatna Klinika Ginekologiczno-Poloznicza
🇵🇱Bialystok, Poland
Clintrials Centre for Clinical Research
🇿🇦Panorama, Western Cape, South Africa
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
University of Cape Town Clinical Research Centre
🇿🇦Cape Town, Western Cape, South Africa
Centro Integral Médico de San Juan del Río S. C.
🇲🇽San Juan del Río, Querétaro, Mexico
Women's wellness Tsushima Ruriko josei life clinic Ginza
🇯🇵Chuo-ku, Tokyo, Japan
St.Luke's International Hospital
🇯🇵Chuoku, Tokyo, Japan
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
🇯🇵Minato, Tokyo, Japan
Medicus AS
🇳🇴Trondheim, Norway
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Centrum Medyczne Chodzki
🇵🇱Lublin, Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
🇵🇱Lublin, Poland
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Yokokura Clinic
🇯🇵Minato-ku, Tokyo, Japan
Wayne State University Physicians Group
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Central Research Associates | Birmingham, AL
🇺🇸Birmingham, Alabama, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Medical Topia Soka Hospital
🇯🇵Soka, Saitama, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kurashiki Medical Clinic
🇯🇵Kurashiki, Okayama, Japan
Fuyo Association Seirei Numazu Hospital
🇯🇵Numazu, Shizuoka, Japan
Sano Wemen's Clinic
🇯🇵Fukuoka, Japan
Unoki Clinic
🇯🇵Kagoshima, Japan
Advanced Women's Health Institute | Denver Office, Greenwood Village, CO
🇺🇸Parker, Colorado, United States
Women's Health Care Research | San Diego, CA
🇺🇸San Diego, California, United States
IntimMedicine | Washington, DC
🇺🇸Washington, District of Columbia, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Axcess Medical Research, LLC
🇺🇸Loxahatchee Groves, Florida, United States
Fellows Research Alliance, Inc | Savannah, GA
🇺🇸Savannah, Georgia, United States
Journey Medical Research
🇺🇸Snellville, Georgia, United States
Paramount Research Solutions | College Park Location
🇺🇸College Park, Georgia, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Johns Hopkins University School of Medicine
🇺🇸Columbia, Maryland, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Eastern Carolina Women's Center | New Bern, NC
🇺🇸New Bern, North Carolina, United States
Unified Women's Clinical Research - Morehead City
🇺🇸Morehead City, North Carolina, United States
M3 Wake Research | Raleigh, NC
🇺🇸Raleigh, North Carolina, United States
Women's Health Alliance
🇺🇸Raleigh, North Carolina, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Women's Physician Group
🇺🇸Memphis, Tennessee, United States
VitaLink Research - Greenville
🇺🇸Greenville, South Carolina, United States
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The 2nd Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Women's Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumchi, Xinjiang, China
The Second Affliated Hospital of Wenzhou Medicial University
🇨🇳Wenzhou, Zhejiang, China
Beijing Hospital of Traditional Chinese Medicine
🇨🇳Beijing, China
Dr. Smrhova-Kovacs
🇨🇿Tabor, Czechia
Aso Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Primo Women's Clinic
🇯🇵Ebetsu, Hokkaido, Japan
Sapporo Shiroishi Obstetrics and Gynecology Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hashimoto Clinic
🇯🇵Sapporo, Hokkaido, Japan
Sapporo Maternity Women's Minami1jo Clinic
🇯🇵Sapporo, Hokkaido, Japan
Sei Womens Clinic
🇯🇵Bunkyo, Tokyo, Japan
Kato Internal medicine and Gynecology Clinic
🇯🇵Fukui, Japan
Chayamachi ladies Clinic Hommachi
🇯🇵Osaka, Japan
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Valaoras & Lewis OB/GYN
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology
🇺🇸Charleston, South Carolina, United States
Clinical Trials of Viriginia
🇺🇸Richmond, Virginia, United States
Synexus Research, LLC
🇺🇸Richmond, Virginia, United States
Suncoast Clinical Research Inc. | Pasco
🇺🇸Trinity, Florida, United States
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China