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TerminatedPhase 3

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Key facts

Who runs it
Bayer
Where
Albuquerque, Atlanta, Augusta, Beavercreek, Birmingham, Boynton Beach, Brooklyn, Charleston, Charlotte, Clearwater, College Park, Columbia, Covington, Dallas, Dayton, Detroit, Doral, Durham, Encinitas, Englewood, Fort Lauderdale, Fort Worth, Franklin, Greensboro, Greenville, Greenwood Village, Hershey, Hixson, Houston, Irving, Jacksonville, La Mesa, Lake Charles, Lakewood, Lampasas, Las Vegas, Lawrenceville, Lincoln, Little Rock, Loxahatchee Groves, Marrero, Memphis, Metairie, Mobile, Morehead City, Myrtle Beach, Neptune City, New Bern, New Haven, New York, Norfolk, North Chesterfield, Owensboro, Palm Harbor, Palos Heights, Philadelphia, Pikesville, Plano, Portland, Raleigh, Richmond, Saint Cloud, San Antonio, San Diego, Sarasota, Savannah, Shreveport, Snellville, Stamford, Staten Island, Towson, Trinity, Tucson, Washington D.C., West Columbia, Wichita, Wilmington, and Winston-Salem, United StatesSee the 94 sitesAlso in 12 other countries, 125 sites
Status
Terminated
Phase
Phase 3
People taking part
1,272 people enrolled
Started
30 Jun 2017
Ended
11 Jul 2024
Type of study
Interventional, 4 groups
Treatments tested
  • Vilaprisan (BAY1002670)
  • Standard of care
Record updated
28 July 2025
Why it stopped
Due to a change in the development program, the study was closed prematurely.

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Abuse of alcohol, drugs, or medicines (eg, laxatives)
  • 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
  • Undiagnosed abnormal genital bleeding
  • Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
  • Use of other treatments that might interfere with the conduct of the study or the interpretation of the results

Where in United States

Also in 12 other countries, 125 sites

  • Bosque Women's Care | Albuquerque, NMAlbuquerque, United States
  • Agile Clinical Research Trials, LLCAtlanta, United States
  • Atlanta Women's Research Institute, Inc. - AtlantaAtlanta, United States
  • Medisense Inc at Atlantic StationAtlanta, United States
  • Augusta University Medical CenterAugusta, United States
  • Clinical Inquest Center LtdBeavercreek, United States
  • Central Research Associates | Birmingham, ALBirmingham, United States
  • Helix Biomedics LLC | Boynton Beach, FLBoynton Beach, United States
  • SUNY Downstate Health Sciences University - NeurologyBrooklyn, United States
  • MUSC Women's Health - Cannon St.Charleston, United States
  • Atrium Health Fertility CenterCharlotte, United States
  • Women's Medical Research Group, LLCClearwater, United States
  • Paramount Research Solutions | College Park LocationCollege Park, United States
  • Johns Hopkins University School of MedicineColumbia, United States
  • Vista Clinical ResearchColumbia, United States
  • MultiCare Women's Health - CovingtonCovington, United States
  • Discovery Clinical Trials - DallasDallas, United States
  • Miami Valley Hospital - GynecologyDayton, United States
  • Henry Ford Health SystemDetroit, United States
  • Wayne State University Physicians GroupDetroit, United States
  • Doral Medical ResearchDoral, United States
  • Carolina Women's Research & Wellness CenterDurham, United States
  • Diagnamics | Encinitas, CAEncinitas, United States
  • HWC Women's Research Center | Englewood, OHEnglewood, United States
  • M & O Clinical Research, LLCFort Lauderdale, United States
  • Office of Dr. Delbert Alan Johns, MDFort Worth, United States
  • Signature Gyn ServicesFort Worth, United States
  • OB-GYN Physicians, Inc.Franklin, United States
  • Unified Women's Clinical Research - GreensboroGreensboro, United States
  • VitaLink Research - GreenvilleGreenville, United States
  • Advanced Women's Health Institute | Denver Office, Greenwood Village, COGreenwood Village, United States
  • Penn State Milton S. Hershey Medical Center - RadiologyHershey, United States
  • ClinSearch, LLCHixson, United States
  • Advances in Health, INC. | Houston, TXHouston, United States
  • The Woman's Hospital of TexasHouston, United States
  • MacArthur Medical Center - OB/GYNIrving, United States
  • Solutions Through Advanced Research, IncJacksonville, United States
  • Grossmont Center for Clinical ResearchLa Mesa, United States
  • Centex Studies, Inc.Lake Charles, United States
  • Physicians' Research Options, LLC | Red Rocks OBGYNLakewood, United States
  • AdventHealth Family Medicine Clinic LampasasLampasas, United States
  • M3 Wake Research - Clinical Research Center of NevadaLas Vegas, United States
  • Capital Health | Capital Health OBGYN LawrencevilleLawrenceville, United States
  • Women's Clinic of Lincoln, P.C. | Lincoln, NELincoln, United States
  • Lynn Institute of the OzarksLittle Rock, United States
  • University of Arkansas for Medical Sciences - NeurologyLittle Rock, United States
  • Axcess Medical Research, LLCLoxahatchee Groves, United States
  • Praetorian Pharmaceutical Research, LLCMarrero, United States
  • Women's Physician GroupMemphis, United States
  • Southern Clinical Research AssociatesMetairie, United States
  • AMR - Mobile, ALMobile, United States
  • Women's Health Alliance of MobileMobile, United States
  • Unified Women's Clinical Research - Morehead CityMorehead City, United States
  • Venus Gynecology, LLC | Myrtle Beach, SCMyrtle Beach, United States
  • Jersey Shore University Medical CenterNeptune City, United States
  • Eastern Carolina Women's Center | New Bern, NCNew Bern, United States
  • Yale University School Of MedicineNew Haven, United States
  • Columbia University Medical CenterNew York, United States
  • Integrated Medical ProfessionalsNew York, United States
  • Tidewater Clinical Research - NorfolkNorfolk, United States
  • Virginia Physicians For WomenNorth Chesterfield, United States
  • Research Integrity LLCOwensboro, United States
  • Suncoast Clinical Research - Palm HarborPalm Harbor, United States
  • Center For Women's CarePalos Heights, United States
  • Clinical Research Philadelphia | Philadelphia, PAPhiladelphia, United States
  • Drexel University College of Medicine - Obstetrics and GynecologyPhiladelphia, United States
  • Hospital of the University of PennsylvaniaPhiladelphia, United States
  • Baltimore Suburban Health, LLCPikesville, United States
  • Willowbend Health and Wellness AssociatesPlano, United States
  • OHSU Hospital - NeurologyPortland, United States
  • M3 Wake Research | Raleigh, NCRaleigh, United States
  • Women's Health AllianceRaleigh, United States
  • Clinical Trials of ViriginiaRichmond, United States
  • Synexus Research, LLCRichmond, United States
  • ONCOVA Clinical Research, Inc.Saint Cloud, United States
  • Seven Oaks Women's Center - Main Office - Medical CenterSan Antonio, United States
  • M3 Wake Research San Diego - AlvaradoSan Diego, United States
  • West Coast OB/GYN AssociatesSan Diego, United States
  • Women's Health Care Research | San Diego, CASan Diego, United States
  • Swor Women's CareSarasota, United States
  • Fellows Research Alliance, Inc | Savannah, GASavannah, United States
  • Omni Fertility and Laser InstituteShreveport, United States
  • Journey Medical ResearchSnellville, United States
  • Stamford HospitalStamford, United States
  • Richmond ObGyn Associates PCStaten Island, United States
  • Continental Clinical Solutions | Towson, MDTowson, United States
  • Suncoast Clinical Research - New Port RicheyTrinity, United States
  • Visions Clinical Research - TucsonTucson, United States
  • IntimMedicine | Washington, DCWashington D.C., United States
  • Biocentric Health ResarchWest Columbia, United States
  • Professional Research Network of Kansas, LLCWichita, United States
  • PMG Research of WilmingtonWilmington, United States
  • Lyndhurst Clinical ResearchWinston-Salem, United States
  • Valaoras & Lewis OB/GYNWinston-Salem, United States

About the trial

What the trial wants to find out

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

The 4 groups in the trial

  • A1(3/1 regimen)Treatment being tested

    2.0 mg treatment of 12 weeks, each separated by 1 bleeding break

    Treatment: Vilaprisan (BAY1002670)

  • A2(6/2 regimen)Treatment being tested

    2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break

    Treatment: Vilaprisan (BAY1002670)

  • A3(3/2 regimen)Treatment being tested

    2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break

    Treatment: Vilaprisan (BAY1002670)

  • B(Standard of care)Other group

    Standard of care as determined by the investigators, this could be watch \& wait or non-hormonal medical treatment

    Treatment: Standard of care

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
28 July 2025