Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,272

Participants

Timeline

Start Date

June 30, 2017

Primary Completion Date

May 10, 2019

Study Completion Date

July 11, 2024

Conditions
Uterine Fibroids
Interventions
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).

OTHER

Standard of care

Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)

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)

Trial Locations (219)

2

University of Pretoria, Clinical Research Unit, Pretoria

141

Dr L Reynders Practice, Lyttelton Manor

1330

Cukurova Universitesi Tip Fakultesi Hastanesi, Adana

1605

Kirkeparken Spesialistpraksis, Fredrikstad

4052

Durban International Clinical Research Site, Wentworth

4321

Femway Inc, Umhlanga

5221

Nesttun Spesialistpraksis AS, Nesttun

6100

Ankara Universitesi Tip Fakultesi Hastanesi, Ankara

7014

Medicus AS, Trondheim

7405

Drs AEVITAS Clinic (Pty) Ltd, Cape Town

7500

Clintrials Centre for Clinical Research, Panorama

7925

University of Cape Town Clinical Research Centre, Cape Town

10016

Integrated Medical Professionals, New York

10032

Columbia University Medical Center, New York

10306

Richmond ObGyn Associates PC, Staten Island

10330

King Chulalongkorn Memorial Hospital, Bangkok

10700

Siriraj Hospital, Mahidol, Bangkok

11203

SUNY Downstate Health Sciences University - Neurology, Brooklyn

16059

Uludag Universitesi Tip Fakultesi, Bursa

17033

Penn State Milton S. Hershey Medical Center - Radiology, Hershey

19102

Drexel University College of Medicine - Obstetrics and Gynecology, Philadelphia

19104

Hospital of the University of Pennsylvania -, Philadelphia

21044

Johns Hopkins University School of Medicine, Columbia

21208

Baltimore Suburban Health, LLC, Pikesville

23225

Clinical Trials of Viriginia, Richmond

23226

Synexus Research, LLC, Richmond

23235

Virginia Physicians For Women, North Chesterfield

23502

Tidewater Clinical Research - Norfolk, Norfolk

23851

OB-GYN Physicians, Inc., Franklin

27103

Lyndhurst Clinical Research, Winston-Salem

Valaoras & Lewis OB/GYN, Winston-Salem

27408

Unified Women's Clinical Research - Greensboro, Greensboro

27607

Women's Health Alliance, Raleigh

27713

Carolina Women's Research & Wellness Center, Durham

28204

Atrium Health Fertility Center, Charlotte

28401

PMG Research of Wilmington, Wilmington

28557

Unified Women's Clinical Research - Morehead City, Morehead City

29169

Biocentric Health Resarch, West Columbia

29201

Vista Clinical Research, Columbia

29425

MUSC Women's Health - Cannon St., Charleston

29615

VitaLink Research - Greenville, Greenville

30001

The Second Affiliated Hospital of Shanxi Medical University, Taiyuan

30078

Journey Medical Research, Snellville

30328

Agile Clinical Research Trials, LLC, Atlanta

30342

Atlanta Women's Research Institute, Inc. - Atlanta, Atlanta

30364

Medisense Inc at Atlantic Station, Atlanta

30912

Augusta University Medical Center, Augusta

32256

Solutions Through Advanced Research, Inc., Jacksonville

33166

Doral Medical Research, Doral

33316

M & O Clinical Research, LLC, Fort Lauderdale

33470

Axcess Medical Research, LLC, Loxahatchee Groves

33759

Women's Medical Research Group, LLC, Clearwater

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

34098

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi, Istanbul

34239

Swor Women's Care, Sarasota

34655

Suncoast Clinical Research - New Port Richey, Trinity

34684

Suncoast Clinical Research - Palm Harbor, Palm Harbor

34769

ONCOVA Clinical Research, Inc., Saint Cloud

36604

Women's Health Alliance of Mobile, Mobile

36608

AMR - Mobile, AL, Mobile

37421

ClinSearch, LLC, Hixson

38104

Women's Physician Group, Memphis

42303

Research Integrity, LLC, Owensboro

45409

Miami Valley Hospital - Gynecology, Dayton

45431

Clinical Inquest Center, Ltd., Beavercreek

48201

Wayne State University Physicians Group, Detroit

48202

Henry Ford Health System, Detroit

50000

The 2nd Hospital of Hebei Medical University, Shijiazhuang

60463

Center For Women's Care, Palos Heights

64460

"Hospital Universitario José Eleuterio González", Monterrey

67203

Professional Research Network of Kansas, LLC, Wichita

70001

Southern Clinical Research Associates, Metairie

70072

Praetorian Pharmaceutical Research, LLC, Marrero

70601

Centex Studies, Inc., Lake Charles

71118

Omni Fertility and Laser Institute, Shreveport

72204

Lynn Institute of the Ozarks, Little Rock

72205

University of Arkansas for Medical Sciences - Neurology, Little Rock

75062

MacArthur Medical Center - OB/GYN, Irving

75093

Willowbend Health and Wellness Associates, Plano

75231

Discovery Clinical Trials - Dallas, Dallas

76000

Sanatorio Alcocer Pozo S. A. de C. V., Querétaro

76104

Office of Dr. Delbert Alan Johns, MD, Fort Worth

Signature Gyn Services, Fort Worth

76550

AdventHealth Family Medicine Clinic Lampasas, Lampasas

76800

Centro Integral Médico de San Juan del Río S. C., San Juan del Río

77054

The Woman's Hospital of Texas, Houston

77900

Fakultní Nemocnice Olomouc, Olomouc

78229

Seven Oaks Women's Center - Main Office - Medical Center, San Antonio

85712

Visions Clinical Research - Tucson, Tucson

89123

M3 Wake Research - Clinical Research Center of Nevada, Las Vegas

91942

Grossmont Center for Clinical Research, La Mesa

92108

M3 Wake Research San Diego - Alvarado, San Diego

92123

West Coast OB/GYN Associates, San Diego

97239

OHSU Hospital - Neurology, Portland

98042

MultiCare Women's Health - Covington, Covington

100010

Beijing Hospital of Traditional Chinese Medicine, Beijing

100026

Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni., Beijing

100034

Peking University First Hospital - Oncology Department, Beijing

100050

Beijing Tiantan Hospital, Captial Medical University, Beijing

100730

Peking Union Medical College Hospital CAMS, Beijing

115280

City Clinical Hospital #13 Moscow, Moscow

116011

The First Affiliated Hospital of Dalian Medical University, Dalian

117036

Endocrinology Research Center, Moscow

130061

The First Hospital of Jilin University, Changchun

197022

St. Petersburg Medical University n.a. I.P. Pavlov, Saint Petersburg

198329

Granti-Med, Saint Petersburg

199034

Scien. Res. Institute of Obsterics, Gyn. & Reproduction, Saint Petersburg

200030

International Peace Maternity&Child Health Hospital of CWI, Shanghai

200433

Changhai Hospital of Second Military Medical University, Shanghai

210004

Nanjing Maternity and Child Health Care Hospital, Nanjing

210008

NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing

210009

Zhongda Hospital Southeast University, Nanjing

250021

Shandong Provincial Hospital, Jinan

300052

Tianjin Medical University General Hospital, Tianjin

300193

First Teaching Hosptial of Tianjin University of TCM, Tianjin

300199

Tianjin Central Hospital of Gynecology obstetrics, Tianjin

310006

Women's Hospital School of Medicine Zhejiang University, Hangzhou

325000

The Second Affliated Hospital of Wenzhou Medicial University, Wenzhou

330006

Jiangxi Maternal and Child Health Hospital, Nanchang

330200

The Second Affiliated Hospital of Nanchang University, Nanchang

350012

Regional Clinical Hospital #2, Krasnodar

350025

900th Hospital of Joint Logistics Support Force, Fuzhou

430013

Wuhan Tongji Reproductive Medicine Hospital, Wuhan

443072

"Close Joint Stock Company Medical Company IDK", Samara

510120

Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ., Guangzhou

510405

The First Affiliated Hospital of Guangzhou University of TCM, Guangzhou

510630

The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou

518036

Peking University Shenzhen Hospital, Shenzhen

530021

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

570311

Hainan General Hospital, Haikou

610041

West China Second University Hospital, Chengdu

660074

Krasnoyarsk regional perinatal center, Krasnoyarsk

664003

Scientific Center of family health & human reprod. problems, Irkutsk

830011

The First Affiliated Hospital of Xinjiang Medical University, Ürümqi

Alabama

"Central Research Associates , Birmingham, AL"

California

"Diagnamics , Encinitas, CA"

"Women's Health Care Research , San Diego, CA"

Colorado

"Advanced Women's Health Institute , Denver Office, Greenwood Village, CO"

"Physicians' Research Options, LLC , Red Rocks OBGYN"

06511

Yale University School of Medicine, New Haven

06904

Stamford Hospital, Stamford

District of Columbia

"IntimMedicine , Washington, DC"

Florida

"Helix Biomedics LLC , Boynton Beach, FL"

Georgia

"Paramount Research Solutions , College Park Location"

"Fellows Research Alliance, Inc , Savannah, GA"

Maryland

"Continental Clinical Solutions , Towson, MD"

Nebraska

"Women's Clinic of Lincoln, P.C. , Lincoln, NE"

New Jersey

"Capital Health , Capital Health OBGYN Lawrenceville"

07753

Jersey Shore University Medical Center, Neptune City

New Mexico

"Bosque Women's Care , Albuquerque, NM"

North Carolina

"Eastern Carolina Women's Center , New Bern, NC"

"M3 Wake Research , Raleigh, NC"

Ohio

"HWC Women's Research Center , Englewood, OH"

Pennsylvania

"Clinical Research Philadelphia , Philadelphia, PA"

South Carolina

"Venus Gynecology, LLC , Myrtle Beach, SC"

Texas

"Advances in Health, INC. , Houston, TX"

397 01

Centrum gynekologické rehabilitace, s.r.o., Písek

390 03

Dr. Smrhova-Kovacs, Tábor

625 00

Fakultní nemocnice Brno, Brno

370 01

G-Centrum Olomouc s.r.o. Dr. Skrivanek, České Budějovice

500 05

Fakultní Nemocnice Hradec Kralové, Hradec Králové

586 01

MUDr. Radek Fiker s.r.o., Jihlava

389 01

MUDr. Pavlina Nejedla s.r.o., Vodňany

Unknown

"Mehilainen , Mehilainen Kuopio"

"Lääkärikeskus Gyneko, Gynaecological Medical Center , Oulu, Finland"

MISSING

Queen Mary Hospital, Hong Kong

460-0011

Kano's Clinic for Women, Nagoya

274-0063

Kyoritsu Narashinodai Hospital, Funabashi

270-2267

Juno Vesta Clinic Hatta, Matsudo

820-8505

Aso Iizuka Hospital, Iizuka

963-8585

Jusendo Geneal Hospital Yuasa Foundation, Kōriyama

370-0836

Sato Hospital, Takasaki

067-0031

Primo Women's Clinic, Ebetsu

001-0013

Sapporo Maternity Women's Hospital, Sapporo

003-0005

Sapporo Shiroishi Obstetrics and Gynecology Hospital, Sapporo

004-0052

Hashimoto Clinic, Sapporo

060-0001

Ena Odori Clinic, Sapporo

060-0061

Sapporo Maternity Women's Minami1jo Clinic, Sapporo

SAPPORO MEDICAL CENTER, NTT East Corporation, Sapporo

063-0061

Sapporo West Ladies Clinic, Sapporo

064-0808

Yoshio Clinic, Sapporo

920-8530

Ishikawa Prefectural Central Hospital, Kanazawa

760-0076

Asahi-Clinic, Takamatsu

760-8557

Kagawa Prefectural Central Hospital, Takamatsu

212-0021

Second Kawasaki Saiwai Clinic, Kawasaki

710-0824

Kurashiki Medical Clinic, Kurashiki

564-0082

Suita Municipal Hospital, Suita

340-0028

Medical Topia Soka Hospital, Sōka

410-8555

Fuyo Association Seirei Numazu Hospital, Numazu

112-0014

Sei Womens Clinic, Bunkyo

104-0061

Ginza Yoshida Clinic, Chuo-ku

Women's wellness Tsushima Ruriko josei life clinic Ginza, Chuo-ku

104-8560

St.Luke's International Hospital, Chuoku

183-0056

Akazawa Clinic, Fuchū

192-0046

Medical Corp. Seikoukai New Medical Research System Clinic, Hachiōji

105-0001

Toranomon Womens Clinic, Minato

107-0051

Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic, Minato

108-0071

Shirokane Ladies' Clinic, Minato

108-0014

Yokokura Clinic, Minato-ku

157-0061

Kugayama Hospital, Setagaya-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

171-0021

Ikebukuro Metropolitan Clinic, Toshima-ku

910-0845

Kato Internal medicine and Gynecology Clinic, Fukui

810-0062

Sano Wemen's Clinic, Fukuoka

892-0826

Unoki Clinic, Kagoshima

530-0013

Medical corporation keizukai Chayamachi Ladies Clinic, Osaka

541-0048

Chayamachi ladies Clinic Hommachi, Osaka

542-0076

Medical Corporation Koshinkai Nomura Clinic Namba, Osaka

543-0023

Izuma Clinic, Osaka

422-8527

Shizuoka Saiseikai General Hospital, Shizuoka

424-8636

Shizuoka City Shimizu Hospital, Shizuoka

15-244

Prywatna Klinika Ginekologiczno-Poloznicza, Bialystok

40-156

CLINICAL MEDICAL RESEARCH Sp. z o. o., Katowice

40-748

Vita Longa Sp. z o.o., Katowice

40-851

Gyncentrum Sp. z o.o., Katowice

90-602

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr., Lodz

20-093

Centrum Medyczne Chodzki, Lublin

20-400

Specjalistyczny Gabinet Ginekologiczno-Polozniczy, Lublin

TBC

Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT03194646 - Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids | Biotech Hunter | Biotech Hunter