Trial Condition(s):

Uterine Fibroids

Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 4)

Bayer Identifier:

15790

ClinicalTrials.gov Identifier:

NCT03400956

EudraCT Number:

2016-003561-26

Terminated/Withdrawn

Trial Purpose

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo

The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids

Inclusion Criteria
- Women, 18 years or older in good general health
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
- Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method
- An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
- Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) 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
- Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
- 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 (e.g. laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of results
- Undiagnosed abnormal genital bleeding

Trial Summary

Enrollment Goal
103
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Advances in Health, Inc.

Houston, United States, 77030

Status
Completed
 
Locations

Savin Medical Group LLC

Miami Lakes, United States, 33014

Status
Completed
 
Locations

Grossmont Center for Clinical Research

La Mesa, United States, 91942

Status
Completed
 
Locations

Physician Care Clinical Research

Sarasota, United States, 34239

Status
Completed
 
Locations

Solutions Through Advanced Research, Inc.

Jacksonville, United States, 32256

Status
Completed
 
Locations

DMI Research

Pinellas Park, United States, 33782

Status
Completed
 
Locations

Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare

Orlando, United States, 32801

Status
Completed
 
Locations

PMG Research of Wilmington

Wilmington, United States, 28401

Status
Completed
 
Locations

Vista Clinical Research

Columbia, United States, 29201

Status
Completed
 
Locations

Women's Medical Research Group, LLC

Clearwater, United States, 33759

Status
Completed
 
Locations

Seattle Clinical Research Center

Seattle, United States, 98105

Status
Completed
 
Locations

Unified Women's Clinical Research / Ocala, FL

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Vista Health Research

Miami, United States, 33176

Status
Completed
 
Locations

Palmetto Professional Research

Miami, United States, 33186

Status
Completed
 
Locations

Clearview Medical Research, LLC

Canyon Country, United States, 91351

Status
Completed
 
Locations

Diagnamics, Inc.

Encinitas, United States, 92024

Status
Completed
 
Locations

Oviedo Medical Research, LLC

Oviedo, United States, 32765

Status
Completed
 
Locations

Journey Medical Research

Snellville, United States, 30078

Status
Completed
 
Locations

Unified Women’s Clinical Research

Greensboro, United States, 27408

Status
Completed
 
Locations

Miami Dade Medical Research Institute, LLC

Miami, United States, 33176

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia, United States, 19104

Status
Completed
 
Locations

New England Center for Clinical Research, Inc.

Fall River, United States, 02720

Status
Completed
 
Locations

The Clinical Trial Center, LLC

Jenkintown, United States, 19046

Status
Completed
 
Locations

Altea Research Institute

Las Vegas, United States, 89102

Status
Completed
 
Locations

Women's Healthcare Associates, PA

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Chattanooga Women for Women

Hixson, United States, 37343

Status
Completed
 
Locations

Discovery Clinical Trials

Dallas, United States, 75231

Status
Completed
 
Locations

Vital Pharma Research

Hialeah, United States, 33016

Status
Completed
 
Locations

Discovery Clinical Trials

San Antonio, United States, 78258

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Health Awareness, Inc.

Jupiter, United States, 33458

Status
Completed
 
Locations

A Premier Medical Research of Florida, LLC

Orange City, United States, 32763

Status
Completed
 
Locations

Artemis Institute for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

Gynekologicka ambulance - Zabreh na Morave

Zabreh na Morave, Czech Republic, 78901

Status
Completed
 
Locations

Gynekologie MUDr. Jaromir Karban s.r.o

Neratovice, Czech Republic, 277 11

Status
Completed
 
Locations

Privatni gynekologicko-porodnicka ordinace

Praha, Czech Republic, 16000

Status
Completed
 
Locations

GYNEVI s.r.o.

Rokycany, Czech Republic, 337 01

Status
Completed
 
Locations

GynPorCentrum s.r.o.

Krnov, Czech Republic, 794 01

Status
Completed
 
Locations

Center of Reproductive Medicine

Webster, United States, 77598

Status
Completed
 
Locations

Suncoast Research Group, LLC

Miami, United States, 33135

Status
Completed
 
Locations

Tidewater Physicians for Women

Norfolk, United States, 23502

Status
Completed
 
Locations

Oregon Health and Science University

Portland, United States, 97239-3011

Status
Completed
 
Locations

Genoma Research Group, Inc.

Miami, United States, 33165

Status
Completed
 
Locations

South Florida Clinical Research Institute

Margate, United States, 33073

Status
Completed
 
Locations

Florida Research Center, Inc.

Miami, United States, 33174

Status
Completed
 
Locations

Advanced Pharma CR, LLC

Miami, United States, 33147

Status
Completed
 
Locations

National Research Institute

Huntington Park, United States, 90255

Status
Completed
 
Locations

Gadolin Research

Beaumont, United States, 77702

Status
Completed
 
Locations

West Coast OB/GYN Associates

LA Mesa, United States, 91942

Status
Completed
 
Locations

Smolensk State Medical University

Smolensk, Russia, 214019

Status
Completed
 
Locations

Med Estetic Center

St. Petersburg, Russia, 192177

Status
Completed
 
Locations

Close Joint Stock Company "Medical Company IDK"

Samara, Russia, 443067

Status
Completed
 
Locations

Maternity Hospital, 17

Saint-Petersburg, Russia, 192174

Status
Completed
 
Locations

"Granti-Med"

St. Petersburg, Russia, 198329

Status
Completed
 
Locations

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

St. Petersburg, Russia, 199034

Status
Completed
 
Locations

Altai State Medical University

Barnaul, Russia, 656038

Status
Completed
 
Locations

Vinnytsia City Clinical Maternity Hospital No 2

Vinnytsia, Ukraine, 21001

Status
Completed
 
Locations

Chernivtsi Regional Perinatal Center

Chernivtsi, Ukraine, 58001

Status
Completed
 
Locations

Zaporizhzhia Regional Clinical Hospital

Zaporizhzhya, Ukraine, 69103

Status
Completed
 
Locations

National Research Institute

Panorama City, United States, 91402

Status
Completed
 
Locations

Hashimoto Clinic

Sapporo, Japan, 004-0052

Status
Completed
 
Locations

Yoshio Clinic

Sapporo, Japan, 064-0808

Status
Completed
 
Locations

Tokeidai Memorial Clinic

Sapporo, Japan, 060-0031

Status
Completed
 
Locations

Medical Topia Soka Hospital

Soka, Japan, 340-0028

Status
Completed
 
Locations

Ena Odori Clinic

Sapporo, Japan, 060-0001

Status
Completed
 
Locations

Kagawa Prefectural Central Hospital

Takamatsu, Japan, 760-8557

Status
Completed
 
Locations

Unoki Clinic

Kagoshima, Japan, 892-0826

Status
Completed
 
Locations

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan, 861-8520

Status
Completed
 
Locations

Asahi-Clinic.

Takamatsu, Japan, 760-0076

Status
Completed
 
Locations

Kyoto city Hospital

Nakagyo-ku, Japan, 604-8845

Status
Completed
 
Locations

Takamatsu Red Cross Hospital

Takamatsu, Japan, 760-0017

Status
Completed
 
Locations

Gokeikai Osaka Kaisei Hospital

Osaka, Japan, 532-0003

Status
Completed
 
Locations

Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine

Kagoshima, Japan, 892-0845

Status
Completed
 
Locations

Matsudo City General Hospital

Matsudo, Japan, 270-2296

Status
Completed
 
Locations

Osaka City Hospital Organization Osaka City General Hospital

Osaka, Japan, 534-0021

Status
Completed
 
Locations

Ijinkai Takeda General Hospital

Kyoto, Japan, 601-1495

Status
Completed
 
Locations

Tsujinaka Hospital Kashiwanoha

Kashiwa, Japan, 277-0871

Status
Completed
 
Locations

Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi

Osaka, Japan, 542-0086

Status
Completed
 
Locations

FOUR SEASONS LADIES’ CLINIC

Kumamoto, Japan, 860-0846

Status
Completed
 
Locations

Funabashi Municipal Medical Center

Funabashi, Japan, 273-8588

Status
Completed
 
Locations

Saiseikai Fukuoka General Hospital

Fukuoka, Japan, 810-0001

Status
Completed
 
Locations

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Japan, 251-0041

Status
Completed
 
Locations

OMI MEDICAL CENTER

Kusatsu, Japan, 525-8585

Status
Completed
 
Locations

Women Partners in Health Obstetrics & Gynecology (OB/GYN)

Austin, United States, 78705

Status
Completed
 
Locations

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Kosumo Clinic

Kako-gun, Japan, 675-1115

Status
Completed
 
Locations

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan, 602-8026

Status
Completed
 

Trial Design