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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03194646
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Condition or disease Intervention/treatment Phase
Leiomyoma Drug: Vilaprisan (BAY1002670) Other: Standard of care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : September 13, 2021
Estimated Study Completion Date : September 13, 2021

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 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 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 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes episodes(6/2 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)

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 2 bleeding episodesepisodes(3/2 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)

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)




Primary Outcome Measures :
  1. Percentage change in bone mineral density (BMD) of lumbar spine [ Time Frame: One year ]

    The percentage change in BMD of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated subjects with measurements at those 2 time points in each treatment group.

    The study will be continued after the date of primary completion. Study results will be updated once the study is completed, after LPLV.



Secondary Outcome Measures :
  1. Number of bleeding days [ Time Frame: Approximately 1 year for subgroup 1 and approximately 2 years for subgroup 2 ]
    Number 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 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194646


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Locations
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United States, Alabama
Central Research Associates, Inc.
Birmingham, Alabama, United States, 35205
Women's Health Alliance of Mobile
Mobile, Alabama, United States, 36607
Coastal Clinical Research, Inc
Mobile, Alabama, United States, 36608
United States, Arizona
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
United States, Arkansas
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Diagnamics, Inc.
Encinitas, California, United States, 92024
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
Medical Center for Clinical Research
San Diego, California, United States, 92108
Womens Health Care Research Corporation
San Diego, California, United States, 92111
West Coast OB/GYN Associates
San Diego, California, United States, 92123
United States, Colorado
Advanced Women's Health Institute
Greenwood Village, Colorado, United States, 80111
Physicians Research Options, LLC
Lakewood, Colorado, United States, 80228
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, District of Columbia
Office of Dr. James A. Simon, MD
Washington, District of Columbia, United States, 20036
United States, Florida
Helix Biomedics, LLC
Boynton Beach, Florida, United States, 33436
Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
Doral, Florida, United States, 33166
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States, 33316
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States, 32256
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, United States, 33470
Suncoast Clinical Research Center, Inc.
New Port Richey, Florida, United States, 34652
Suncoast Clinical Research
Palm Harbor, Florida, United States, 34684
ONCOVA Clinical Research, Inc.
Saint Cloud, Florida, United States, 34769
Physician Care Clinical Research
Sarasota, Florida, United States, 34239
United States, Georgia
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, United States, 30342
Medisense Inc at Atlantic Station
Atlanta, Georgia, United States, 30364
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Paramount Research Solutions
College Park, Georgia, United States, 30349
Fellows Research Alliance
Savannah, Georgia, United States, 31406
Journey Medical Research
Snellville, Georgia, United States, 30078
United States, Illinois
Center For Women's Research
Palos Heights, Illinois, United States, 60463
United States, Kansas
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States, 67205-1138
United States, Kentucky
Research Integrity, LLC
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, United States, 70072
Southern Clinical Research Associates LLC
Metairie, Louisiana, United States, 70001
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States, 71118
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Baltimore Suburban Health, LLC
Pikesville, Maryland, United States, 21208
Continental Clinical Solutions, LLC
Towson, Maryland, United States, 21204
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Wayne State University Physicians Group
Southfield, Michigan, United States, 48034
United States, Nebraska
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States, 68510
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89123
United States, New Jersey
Lawrence OB/GYN Associates
Lawrenceville, New Jersey, United States, 08648
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
United States, New Mexico
Bosque Womens Care
Albuquerque, New Mexico, United States, 87109
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Manhattan Medical Research
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
Richmond ObGyn Associates PC
Staten Island, New York, United States, 10306
United States, North Carolina
Carolinas Healthcare System
Charlotte, North Carolina, United States, 28204
Carolina Women's Research & Wellness Center
Durham, North Carolina, United States, 27713
Unified Women's Clinical Research
Greensboro, North Carolina, United States, 27408
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, United States, 28557
Eastern Carolina Women's Center
New Bern, North Carolina, United States, 28562
Women's Health Alliance
Raleigh, North Carolina, United States, 27607
Wake Research Asssociates
Raleigh, North Carolina, United States, 27612
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Valaoras & Lewis OB/GYN
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Clinical Inquest Center, Ltd.
Beavercreek, Ohio, United States, 45432
Miami Valley Hospital
Dayton, Ohio, United States, 45409-2793
HWC Women's Research Center
Englewood, Ohio, United States, 45322
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Vista Clinical Research
Columbia, South Carolina, United States, 29201
Greenville Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Magnolia OB/GYN Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Invocare Clinical Research Center, LLC
West Columbia, South Carolina, United States, 29169
United States, Tennessee
ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Women's Physician Group
Memphis, Tennessee, United States, 38104
United States, Texas
Discovery Clinical Trials
Dallas, Texas, United States, 75231
Signature GYN Services, Pllc
Fort Worth, Texas, United States, 76104-4145
Office of Dr. Delbert Alan Johns, MD
Fort Worth, Texas, United States, 76104
Willowbend Health & Wellness Associates
Frisco, Texas, United States, 75035
Advances in Health, Inc.
Houston, Texas, United States, 77030
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
Centex Studies, Inc.
Houston, Texas, United States, 77058
MacArthur OB/GYN Mangement, LLC
Irving, Texas, United States, 75062
Family Medicine Clinic
Lampasas, Texas, United States, 76550
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, Virginia
OB-GYN Physicians, Inc.
Franklin, Virginia, United States, 23851
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502
Clinical Trials of Viriginia
Richmond, Virginia, United States, 23225
Synexus Research, LLC
Richmond, Virginia, United States, 23226
Virginia Physicians For Women
Richmond, Virginia, United States, 23235
United States, Washington
MultiCare Health Systems Women's Health Care
Covington, Washington, United States, 98042
China, Fujian
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China, 350025
China, Guangdong
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, China, 510120
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, China, 510405
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510630
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
China, Hainan
Hainan General Hospital
Haikou, Hainan, China, 570311
China, Hebei
The 2nd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Hubei
Center for Reproductive Medicine,Tongji Medical college,HUST
Wuhan, Hubei, China, 430013
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, China, 210008
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
China, Jiangxi
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330006
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Liaoning
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
China, Shanxi
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
China, Sichuan
West China Second University Hospital
Chengdu, Sichuan, China, 610041
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
China, Zhejiang
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310006
The Second Affliated Hospital of Wenzhou Medicial University
Wenzhou, Zhejiang, China, 325000
China
Beijing Hospital of Traditional Chinese Medicine
Beijing, China, 100010
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
Beijing, China, 100026
Beijing Tiantan Hospital, Captial Medical University
Beijing, China, 100050
Peking Union Medical College Hospital CAMS
Beijing, China, 100730
Peking University First Hospital
Beijing, China
International Peace Maternity&Child Health Hospital of CWI
Shanghai, China, 200030
Changhai Hospital of Second Military Medical University
Shanghai, China, 200433
Tianjin Medical University General Hospital
Tianjin, China, 300052
First Teaching Hosptial of Tianjin University of TCM
Tianjin, China, 300193
Tianjin Central Hospital of Gynecology obstetrics
Tianjin, China, 300199
Czechia
Fakultni Nemocnice Brno
Brno, Czechia, 625 00
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, Czechia, 50005
MUDr. Radek Fiker s.r.o.
Jihlava, Czechia, 586 01
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, Czechia, 772 00
Fakultni Nemocnice Olomouc
Olomouc, Czechia, 775 20
Centrum gynekologicke rehabilitace
Pisek, Czechia, 39701
Dr. Smrhova-Kovacs
Tabor, Czechia, 39003
Gynekologie MUDr. Pavlina Nejedla s.r.o.
Vodnany, Czechia, 389 01
Finland
VL-Medi Oy
Helsinki, Finland, 00260
Keski-Suomen keskussairaala
Jyväskylä, Finland, 40620
Kymenlaakson keskussairaala
Kotka, Finland, 48210
Lääkäriasema Cantti Oy
Kuopio, Finland, 70110
Lääkärikeskus Gyneko
Oulu, Finland, 90100
Hong Kong
Queen Mary Hospital
Hongkong, Hong Kong
Japan
Kano's Clinic for Women
Nagoya, Aichi, Japan, 460-0011
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, Japan, 274-0063
Juno Vesta Clinic Hatta
Matsudo, Chiba, Japan, 270-2267
Iizuka Hospital
Iizuka, Fukuoka, Japan, 820-8505
Jusendo Hospital
Koriyama, Fukushima, Japan, 963-8585
Sato Hospital
Takasaki, Gunma, Japan, 370-0836
Primo Women's Clinic
Ebetsu, Hokkaido, Japan, 061-0031
Sapporo Maternity Women's Hospital
Sapporo, Hokkaido, Japan, 001-0013
Sapporo Shiroishi Obstetrics and Gynecology Hospital
Sapporo, Hokkaido, Japan, 003-0005
Hashimoto Clinic
Sapporo, Hokkaido, Japan, 004-0052
Ena Odori Clinic
Sapporo, Hokkaido, Japan, 060-0001
Sapporo Maternity Women's Minami1jo Clinic
Sapporo, Hokkaido, Japan, 060-0061
SAPPORO MEDICAL CENTER, NTT East Corporation
Sapporo, Hokkaido, Japan, 060-0061
Sapporo West Ladies Clinic
Sapporo, Hokkaido, Japan, 063-0061
Yoshio Clinic
Sapporo, Hokkaido, Japan, 064-0808
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa, Japan, 920-8530
Asahi clinic
Takamatsu, Kagawa, Japan, 760-0076
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa, Japan, 760-8557
Second Kawasaki Saiwai Clinic
Kawasaki, Kanagawa, Japan, 212-0021
Kurashiki Medical Clinic
Kurashiki, Okayama, Japan, 710-0824
Suita Municipal Hospital
Suita, Osaka, Japan, 564-0082
Medical Topia Soka Hospital
Soka, Saitama, Japan, 340-0028
Fuyo Association Seirei Numazu Hospital
Numazu, Shizuoka, Japan, 410-8555
Sei Womens Clinic
Bunkyo, Tokyo, Japan, 112-0014
Ginza Yoshida Clinic
Chuo-ku, Tokyo, Japan, 104-0061
Women's wellness Tsushima Ruriko josei life clinic Ginza
Chuo-ku, Tokyo, Japan, 104-0061
St.Luke's International Hospital
Chuoku, Tokyo, Japan, 104-8560
Akazawa Clinic
Fuchu, Tokyo, Japan, 183-0056
Medical Corp. Seikoukai New Medical Research System Clinic
Hachioji, Tokyo, Japan, 192-0046
Yokokura Clinic
Minato-ku, Tokyo, Japan, 108-0014
Toranomon Womens Clinic
Minato, Tokyo, Japan, 105-0001
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
Minato, Tokyo, Japan, 107-0051
Shirokane Ladies' Clinic
Minato, Tokyo, Japan, 108-0071
Kugayama Hospital
Setagaya-ku, Tokyo, Japan, 157-0061
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, Japan, 171-0021
Kato Internal medicine and Gynecology Clinic
Fukui, Japan, 910-0845
Sano Wemen's Clinic
Fukuoka, Japan, 810-0062
Unoki Clinic
Kagoshima, Japan, 892-0826
Medical corporation keizukai Chayamachi Ladies Clinic
Osaka, Japan, 530-0013
Chayamachi ladies Clinic Hommachi
Osaka, Japan, 541-0048
Medical Corporation Koshinkai Nomura Clinic Namba
Osaka, Japan, 542-0076
Izuma Clinic
Osaka, Japan, 543-0023
Shizuoka Saiseikai General Hospital
Shizuoka, Japan, 422-8527
Shizuoka City Shimizu Hospital
Shizuoka, Japan, 424-8636
Mexico
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo Leon, Mexico
Centro Integral Médico Sjr S. C.
San Juan del Río, Querétaro, Mexico, 76800
Sanatorio Alcocer Pozo S. A. de C. V.
Querétaro, Mexico, 76000
Norway
Kirkeparken Spesialistpraksis
Fredrikstad, Norway, 1605
Nesttun Spesialistpraksis AS
Nesttun, Norway, 5221
Stavanger Universitetssjukehus
Stavanger, Norway, 4011
Medicus AS
Trondheim, Norway, 7014
Poland
Prywatna Klinika Ginekologiczno-Poloznicza
Bialystok, Poland, 15-244
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, Poland, 40-001
Vita Longa Sp. z o.o.
Katowice, Poland, 40-748
Gyncentrum Clinic Sp. z o.o.
Katowice, Poland, 40-851
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, Poland, 90-602
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, Poland, 20-064
Centrum Medyczne Chodzki
Lublin, Poland, 20-093
Russian Federation
Scientific Center of family health & human reprod. problems
Irkutsk, Russian Federation, 664003
Regional Clinical Hospital #2
Krasnodar, Russian Federation, 350012
Krasnoyarsk State Medical University
Krasnoyarsk, Russian Federation, 660022
City Clinical Hospital #13
Moscow, Russian Federation, 115280
Endocrinology Scientific Centre
Moscow, Russian Federation, 117036
Close Joint Stock Company "Medical Company IDK"
Samara, Russian Federation, 443067
St. Petersburg Medical University n.a. I.P. Pavlov
St. Petersburg, Russian Federation, 197022
"Granti-Med"
St. Petersburg, Russian Federation, 198329
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
St. Petersburg, Russian Federation, 199034
South Africa
Dr L Reynders Practice
Lyttelton Manor, Gauteng, South Africa, 0141
University of Pretoria, Clinical Research Unit
Pretoria, Gauteng, South Africa, 0002
Ingenuity House
Umhlanga, Kwazulu-Natal, South Africa, 4321
Durban International Clinical Research Site
Wentworth, Kwazulu-Natal, South Africa, 4052
Drs AEVITAS Clinic (Pty) Ltd
Cape Town, Western Cape, South Africa, 7405
TREAD Research cc
Cape Town, Western Cape, South Africa, 7500
University of Cape Town Clinical Research Centre
Cape Town, Western Cape, South Africa, 7925
Clintrials Centre for Clinical Research
Panorama, Western Cape, South Africa, 7500
Thailand
Chulalongkorn Hospital
Bangkok, Thailand, 10330
Siriraj Hospital, Mahidol
Bangkok, Thailand, 10700
Turkey
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, Turkey, 01330
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey, 6100
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
Ankara, Turkey
Uludag Universitesi Tip Fakultesi
Bursa, Turkey, 16059
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, Turkey, 34093
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey, 34098
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03194646     History of Changes
Other Study ID Numbers: 16953
2016-004822-41 ( EudraCT Number )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Uterine Fibroid

Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases