Study Stopped
Due to a change in the development program, the study was closed prematurely.
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
2 other identifiers
interventional
1,272
13 countries
219
Brief Summary
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2017
Longer than P75 for phase_3
219 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedStudy Start
First participant enrolled
June 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedResults Posted
Study results publicly available
August 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2024
CompletedJuly 28, 2025
July 1, 2025
1.9 years
June 20, 2017
June 21, 2021
July 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of Bleeding Days
Treatment phase: approximately 1 year
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)
Change From Baseline in Endometrial Thickness
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
Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Study Arms (4)
A1(3/1 regimen)
EXPERIMENTAL2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
A2(6/2 regimen)
EXPERIMENTAL2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
A3(3/2 regimen)
EXPERIMENTAL2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
B(Standard of care)
OTHERStandard of care as determined by the investigators, this could be watch \& wait or non-hormonal medical treatment
Interventions
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).
Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (219)
Central Research Associates | Birmingham, AL
Birmingham, Alabama, 35205, United States
Women's Health Alliance of Mobile
Mobile, Alabama, 36604, United States
AMR - Mobile, AL
Mobile, Alabama, 36608, United States
Visions Clinical Research - Tucson
Tucson, Arizona, 85712, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
University of Arkansas for Medical Sciences - Neurology
Little Rock, Arkansas, 72205, United States
Diagnamics | Encinitas, CA
Encinitas, California, 92024, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
M3 Wake Research San Diego - Alvarado
San Diego, California, 92108, United States
Women's Health Care Research | San Diego, CA
San Diego, California, 92111, United States
West Coast OB/GYN Associates
San Diego, California, 92123, United States
Advanced Women's Health Institute | Denver Office, Greenwood Village, CO
Greenwood Village, Colorado, 80111, United States
Physicians' Research Options, LLC | Red Rocks OBGYN
Lakewood, Colorado, 80228, United States
Yale University School of Medicine
New Haven, Connecticut, 06511, United States
Stamford Hospital
Stamford, Connecticut, 06904, United States
IntimMedicine | Washington, DC
Washington D.C., District of Columbia, 20036, United States
Helix Biomedics LLC | Boynton Beach, FL
Boynton Beach, Florida, 33435, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Doral Medical Research
Doral, Florida, 33166, United States
M & O Clinical Research, LLC
Fort Lauderdale, Florida, 33316, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, 33470, United States
Suncoast Clinical Research - Palm Harbor
Palm Harbor, Florida, 34684, United States
ONCOVA Clinical Research, Inc.
Saint Cloud, Florida, 34769, United States
Swor Women's Care
Sarasota, Florida, 34239, United States
Suncoast Clinical Research - New Port Richey
Trinity, Florida, 34655, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
Atlanta Women's Research Institute, Inc. - Atlanta
Atlanta, Georgia, 30342, United States
Medisense Inc at Atlantic Station
Atlanta, Georgia, 30364, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Paramount Research Solutions | College Park Location
College Park, Georgia, 30349, United States
Fellows Research Alliance, Inc | Savannah, GA
Savannah, Georgia, 31406, United States
Journey Medical Research
Snellville, Georgia, 30078, United States
Center For Women's Care
Palos Heights, Illinois, 60463, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072, United States
Southern Clinical Research Associates
Metairie, Louisiana, 70001, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118, United States
Johns Hopkins University School of Medicine
Columbia, Maryland, 21044, United States
Baltimore Suburban Health, LLC
Pikesville, Maryland, 21208, United States
Continental Clinical Solutions | Towson, MD
Towson, Maryland, 21204, United States
Wayne State University Physicians Group
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Women's Clinic of Lincoln, P.C. | Lincoln, NE
Lincoln, Nebraska, 68510, United States
M3 Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, 89123, United States
Capital Health | Capital Health OBGYN Lawrenceville
Lawrenceville, New Jersey, 08648, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Bosque Women's Care | Albuquerque, NM
Albuquerque, New Mexico, 87109, United States
SUNY Downstate Health Sciences University - Neurology
Brooklyn, New York, 11203, United States
Integrated Medical Professionals
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Richmond ObGyn Associates PC
Staten Island, New York, 10306, United States
Atrium Health Fertility Center
Charlotte, North Carolina, 28204, United States
Carolina Women's Research & Wellness Center
Durham, North Carolina, 27713, United States
Unified Women's Clinical Research - Greensboro
Greensboro, North Carolina, 27408, United States
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, 28557, United States
Eastern Carolina Women's Center | New Bern, NC
New Bern, North Carolina, 28562, United States
Women's Health Alliance
Raleigh, North Carolina, 27607, United States
M3 Wake Research | Raleigh, NC
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Valaoras & Lewis OB/GYN
Winston-Salem, North Carolina, 27103, United States
Clinical Inquest Center, Ltd.
Beavercreek, Ohio, 45431, United States
Miami Valley Hospital - Gynecology
Dayton, Ohio, 45409, United States
HWC Women's Research Center | Englewood, OH
Englewood, Ohio, 45322, United States
OHSU Hospital - Neurology
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center - Radiology
Hershey, Pennsylvania, 17033, United States
Drexel University College of Medicine - Obstetrics and Gynecology
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania -
Philadelphia, Pennsylvania, 19104, United States
Clinical Research Philadelphia | Philadelphia, PA
Philadelphia, Pennsylvania, 19114, United States
MUSC Women's Health - Cannon St.
Charleston, South Carolina, 29425, United States
Vista Clinical Research
Columbia, South Carolina, 29201, United States
VitaLink Research - Greenville
Greenville, South Carolina, 29615, United States
Venus Gynecology, LLC | Myrtle Beach, SC
Myrtle Beach, South Carolina, 29572, United States
Biocentric Health Resarch
West Columbia, South Carolina, 29169, United States
ClinSearch, LLC
Hixson, Tennessee, 37421, United States
Women's Physician Group
Memphis, Tennessee, 38104, United States
Discovery Clinical Trials - Dallas
Dallas, Texas, 75231, United States
Office of Dr. Delbert Alan Johns, MD
Fort Worth, Texas, 76104, United States
Signature Gyn Services
Fort Worth, Texas, 76104, United States
Advances in Health, INC. | Houston, TX
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
MacArthur Medical Center - OB/GYN
Irving, Texas, 75062, United States
AdventHealth Family Medicine Clinic Lampasas
Lampasas, Texas, 76550, United States
Willowbend Health and Wellness Associates
Plano, Texas, 75093, United States
Seven Oaks Women's Center - Main Office - Medical Center
San Antonio, Texas, 78229, United States
OB-GYN Physicians, Inc.
Franklin, Virginia, 23851, United States
Tidewater Clinical Research - Norfolk
Norfolk, Virginia, 23502, United States
Virginia Physicians For Women
North Chesterfield, Virginia, 23235, United States
Clinical Trials of Viriginia
Richmond, Virginia, 23225, United States
Synexus Research, LLC
Richmond, Virginia, 23226, United States
MultiCare Women's Health - Covington
Covington, Washington, 98042, United States
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034, China
Beijing Tiantan Hospital, Captial Medical University
Beijing, Beijing Municipality, 100050, China
900th Hospital of Joint Logistics Support Force
Fuzhou, Fujian, 350025, China
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The 2nd Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000, China
Wuhan Tongji Reproductive Medicine Hospital
Wuhan, Hubei, 430013, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200, China
The First Hospital of Jilin University
Changchun, Jilin, 130061, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30001, China
West China Second University Hospital
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
The Second Affliated Hospital of Wenzhou Medicial University
Wenzhou, Zhejiang, 325000, China
Beijing Hospital of Traditional Chinese Medicine
Beijing, 100010, China
Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.
Beijing, 100026, China
Peking Union Medical College Hospital CAMS
Beijing, 100730, China
International Peace Maternity&Child Health Hospital of CWI
Shanghai, 200030, China
Changhai Hospital of Second Military Medical University
Shanghai, 200433, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
First Teaching Hosptial of Tianjin University of TCM
Tianjin, 300193, China
Tianjin Central Hospital of Gynecology obstetrics
Tianjin, 300199, China
Centrum gynekologické rehabilitace, s.r.o.
Písek, Jihoceský Kraj, 397 01, Czechia
Dr. Smrhova-Kovacs
Tábor, Jihočeský kraj, 390 03, Czechia
Fakultní nemocnice Brno
Brno, 625 00, Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
České Budějovice, 370 01, Czechia
Fakultní Nemocnice Hradec Kralové
Hradec Králové, 500 05, Czechia
MUDr. Radek Fiker s.r.o.
Jihlava, 586 01, Czechia
Fakultní Nemocnice Olomouc
Olomouc, 77900, Czechia
MUDr. Pavlina Nejedla s.r.o.
Vodňany, 389 01, Czechia
Mehilainen | Mehilainen Kuopio
Kuopio, 70100, Finland
Lääkärikeskus Gyneko, Gynaecological Medical Center | Oulu, Finland
Oulu, 90100, Finland
Queen Mary Hospital
Hong Kong, MISSING, Hong Kong
Kano's Clinic for Women
Nagoya, Aichi-ken, 460-0011, Japan
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, 274-0063, Japan
Juno Vesta Clinic Hatta
Matsudo, Chiba, 270-2267, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, 820-8505, Japan
Jusendo Geneal Hospital Yuasa Foundation
Kōriyama, Fukushima, 963-8585, Japan
Sato Hospital
Takasaki, Gunma, 370-0836, Japan
Primo Women's Clinic
Ebetsu, Hokkaido, 067-0031, Japan
Sapporo Maternity Women's Hospital
Sapporo, Hokkaido, 001-0013, Japan
Sapporo Shiroishi Obstetrics and Gynecology Hospital
Sapporo, Hokkaido, 003-0005, Japan
Hashimoto Clinic
Sapporo, Hokkaido, 004-0052, Japan
Ena Odori Clinic
Sapporo, Hokkaido, 060-0001, Japan
Sapporo Maternity Women's Minami1jo Clinic
Sapporo, Hokkaido, 060-0061, Japan
SAPPORO MEDICAL CENTER, NTT East Corporation
Sapporo, Hokkaido, 060-0061, Japan
Sapporo West Ladies Clinic
Sapporo, Hokkaido, 063-0061, Japan
Yoshio Clinic
Sapporo, Hokkaido, 064-0808, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Asahi-Clinic
Takamatsu, Kagawa-ken, 760-0076, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Second Kawasaki Saiwai Clinic
Kawasaki, Kanagawa, 212-0021, Japan
Kurashiki Medical Clinic
Kurashiki, Okayama-ken, 710-0824, Japan
Suita Municipal Hospital
Suita, Osaka, 564-0082, Japan
Medical Topia Soka Hospital
Sōka, Saitama, 340-0028, Japan
Fuyo Association Seirei Numazu Hospital
Numazu, Shizuoka, 410-8555, Japan
Sei Womens Clinic
Bunkyo, Tokyo, 112-0014, Japan
Ginza Yoshida Clinic
Chuo-ku, Tokyo, 104-0061, Japan
Women's wellness Tsushima Ruriko josei life clinic Ginza
Chuo-ku, Tokyo, 104-0061, Japan
St.Luke's International Hospital
Chuoku, Tokyo, 104-8560, Japan
Akazawa Clinic
Fuchū, Tokyo, 183-0056, Japan
Medical Corp. Seikoukai New Medical Research System Clinic
Hachiōji, Tokyo, 192-0046, Japan
Toranomon Womens Clinic
Minato, Tokyo, 105-0001, Japan
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
Minato, Tokyo, 107-0051, Japan
Shirokane Ladies' Clinic
Minato, Tokyo, 108-0071, Japan
Yokokura Clinic
Minato-ku, Tokyo, 108-0014, Japan
Kugayama Hospital
Setagaya-ku, Tokyo, 157-0061, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021, Japan
Kato Internal medicine and Gynecology Clinic
Fukui, 910-0845, Japan
Sano Wemen's Clinic
Fukuoka, 810-0062, Japan
Unoki Clinic
Kagoshima, 892-0826, Japan
Medical corporation keizukai Chayamachi Ladies Clinic
Osaka, 530-0013, Japan
Chayamachi ladies Clinic Hommachi
Osaka, 541-0048, Japan
Medical Corporation Koshinkai Nomura Clinic Namba
Osaka, 542-0076, Japan
Izuma Clinic
Osaka, 543-0023, Japan
Shizuoka Saiseikai General Hospital
Shizuoka, 422-8527, Japan
Shizuoka City Shimizu Hospital
Shizuoka, 424-8636, Japan
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, 64460, Mexico
Centro Integral Médico de San Juan del Río S. C.
San Juan del Río, Querétaro, 76800, Mexico
Sanatorio Alcocer Pozo S. A. de C. V.
Querétaro, 76000, Mexico
Kirkeparken Spesialistpraksis
Fredrikstad, 1605, Norway
Nesttun Spesialistpraksis AS
Nesttun, 5221, Norway
Medicus AS
Trondheim, 7014, Norway
Prywatna Klinika Ginekologiczno-Poloznicza
Bialystok, 15-244, Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156, Poland
Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Gyncentrum Sp. z o.o.
Katowice, 40-851, Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, 90-602, Poland
Centrum Medyczne Chodzki
Lublin, 20-093, Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, 20-400, Poland
Scientific Center of family health & human reprod. problems
Irkutsk, 664003, Russia
Regional Clinical Hospital #2
Krasnodar, 350012, Russia
Krasnoyarsk regional perinatal center
Krasnoyarsk, 660074, Russia
City Clinical Hospital #13 Moscow
Moscow, 115280, Russia
Endocrinology Research Center
Moscow, 117036, Russia
St. Petersburg Medical University n.a. I.P. Pavlov
Saint Petersburg, 197022, Russia
Granti-Med
Saint Petersburg, 198329, Russia
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
Saint Petersburg, 199034, Russia
Close Joint Stock Company "Medical Company IDK"
Samara, 443072, Russia
Dr L Reynders Practice
Lyttelton Manor, Gauteng, 141, South Africa
University of Pretoria, Clinical Research Unit
Pretoria, Gauteng, 2, South Africa
Femway Inc
Umhlanga, KwaZulu-Natal, 4321, South Africa
Durban International Clinical Research Site
Wentworth, KwaZulu-Natal, 4052, South Africa
Drs AEVITAS Clinic (Pty) Ltd
Cape Town, Western Cape, 7405, South Africa
University of Cape Town Clinical Research Centre
Cape Town, Western Cape, 7925, South Africa
Clintrials Centre for Clinical Research
Panorama, Western Cape, 7500, South Africa
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Siriraj Hospital, Mahidol
Bangkok, 10700, Thailand
Cukurova Universitesi Tip Fakultesi Hastanesi
Adana, 1330, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 6100, Turkey (Türkiye)
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast
Ankara, TBC, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Bursa, 16059, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was ended prematurely. On top of the data included in the previous summary of results after primary completion, this final summary of results adds adverse event data from long term follow-up of subjects in Turkey as per local requirements. This was to ensure follow-up of all Turkish subjects for 5 years after end of study medication intake.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 21, 2017
Study Start
June 30, 2017
Primary Completion
May 10, 2019
Study Completion
July 11, 2024
Last Updated
July 28, 2025
Results First Posted
August 26, 2021
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
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.