Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)
Other
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)

Recruiting Locations

Central Research Associates, Inc.
Birmingham, Alabama 35205

Women's Health Alliance of Mobile
Mobile, Alabama 36607

Coastal Clinical Research, Inc
Mobile, Alabama 36608

Visions Clinical Research - Tucson
Tucson, Arizona 85712

Lynn Institute of the Ozarks
Little Rock, Arkansas 72205

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

Diagnamics, Inc.
Encinitas, California 92024

Grossmont Center for Clinical Research
La Mesa, California 91942

Medical Center for Clinical Research
San Diego, California 92108

Womens Health Care Research Corporation
San Diego, California 92111

West Coast OB/GYN Associates
San Diego, California 92123

Advanced Women's Health Institute
Greenwood Village, Colorado 80111

Physicians Research Options, LLC
Lakewood, Colorado 80228

Stamford Hospital
Stamford, Connecticut 06904

Office of Dr. James A. Simon, MD
Washington, District of Columbia 20036

Helix Biomedics, LLC
Boynton Beach, Florida 33436

Women's Medical Research Group, LLC
Clearwater, Florida 33759

Dr. Victoria Garcia & Associates, LLC Doral Medical Research
Doral, Florida 33166

M & O Clinical Research, LLC
Fort Lauderdale, Florida 33316

Solutions Through Advanced Research, Inc.
Jacksonville, Florida 32256

Axcess Medical Research, LLC
Loxahatchee Groves, Florida 33470

Suncoast Clinical Research Center, Inc.
New Port Richey, Florida 34652

Suncoast Clinical Research
Palm Harbor, Florida 34684

ONCOVA Clinical Research, Inc.
Saint Cloud, Florida 34769

Physician Care Clinical Research
Sarasota, Florida 34239

Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328

Atlanta Women's Research Institute, Inc.
Atlanta, Georgia 30342

Medisense Inc at Atlantic Station
Atlanta, Georgia 30364

Paramount Research Solutions
College Park, Georgia 30349

Fellows Research Alliance
Savannah, Georgia 31406

Journey Medical Research
Snellville, Georgia 30078

Center For Women's Research
Palos Heights, Illinois 60463

Professional Research Network of Kansas, LLC
Wichita, Kansas 67205-1138

Research Integrity, LLC
Owensboro, Kentucky 42303

Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana 70072

Southern Clinical Research Associates LLC
Metairie, Louisiana 70001

Omni Fertility and Laser Institute
Shreveport, Louisiana 71118

Johns Hopkins University School of Medicine
Baltimore, Maryland 21205

Baltimore Suburban Health, LLC
Pikesville, Maryland 21208

Continental Clinical Solutions, LLC
Towson, Maryland 21204

Wayne State University Physicians Group
Southfield, Michigan 48034

Women's Clinic of Lincoln, PC
Lincoln, Nebraska 68510

Clinical Research Center of Nevada
Las Vegas, Nevada 89123

Lawrence OB/GYN Associates
Lawrenceville, New Jersey 08648

Jersey Shore University Medical Center
Neptune, New Jersey 07753

Bosque Womens Care
Albuquerque, New Mexico 87109

SUNY Downstate Medical Center
Brooklyn, New York 11203

Manhattan Medical Research
New York, New York 10016

Columbia University Medical Center
New York, New York 10032

Richmond ObGyn Associates PC
Staten Island, New York 10306

Carolinas Healthcare System
Charlotte, North Carolina 28204

Carolina Women's Research & Wellness Center
Durham, North Carolina 27713

Unified Women's Clinical Research
Greensboro, North Carolina 27408

Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina 28557

Eastern Carolina Women's Center
New Bern, North Carolina 28562

Women's Health Alliance
Raleigh, North Carolina 27607

Wake Research Asssociates
Raleigh, North Carolina 27612

PMG Research of Wilmington
Wilmington, North Carolina 28401

Lyndhurst Clinical Research
Winston-Salem, North Carolina 27103

Valaoras & Lewis OB/GYN
Winston-Salem, North Carolina 27103

Clinical Inquest Center, Ltd.
Beavercreek, Ohio 45432

Wright State Physicians
Dayton, Ohio 45409

HWC Women's Research Center
Englewood, Ohio 45322

Oregon Health and Science University
Portland, Oregon 97239

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033-0850

Drexel University College of Medicine
Philadelphia, Pennsylvania 19102

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104

Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania 19114

Medical University of South Carolina
Charleston, South Carolina 29425

Vista Clinical Research
Columbia, South Carolina 29201

Greenville Pharmaceutical Research
Greenville, South Carolina 29615

Magnolia OB/GYN Research Center, LLC
Myrtle Beach, South Carolina 29572

Invocare Clinical Research Center, LLC
West Columbia, South Carolina 29169

Chattanooga Women for Women
Hixson, Tennessee 37343

Women's Physician Group
Memphis, Tennessee 38104

Discovery Clinical Trials
Dallas, Texas 75231

Signature GYN Services, Pllc
Fort Worth, Texas 76104-4145

Office of Dr. Delbert Alan Johns, MD
Fort Worth, Texas 76104

Willowbend Health & Wellness Associates
Frisco, Texas 75035

Advances in Health, Inc.
Houston, Texas 77030

The Woman's Hospital of Texas
Houston, Texas 77054

Centex Studies, Inc.
Houston, Texas 77058

MacArthur OB/GYN Mangement, LLC
Irving, Texas 75062

Family Medicine Clinic
Lampasas, Texas 76550

Clinical Trials of Texas, Inc.
San Antonio, Texas 78229

Tidewater Physicians for Women
Norfolk, Virginia 23502

Synexus Research, LLC
Richmond, Virginia 23226

Virginia Physicians For Women
Richmond, Virginia 23235

MultiCare Health Systems Women's Health Care
Covington, Washington 98042

More Details

NCT ID
NCT03194646
Status
Recruiting
Sponsor
Bayer

Study Contact

Bayer Clinical Trials Contact
(+) 1-888-8422937
clinical-trials-contact@bayer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.