Trial Condition(s):

Leiomyoma

Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 3)

Bayer Identifier:

15787

ClinicalTrials.gov Identifier:

NCT03400943

EudraCT Number:

2017-002997-38

Study Completed

Trial Purpose

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan 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 ≥ 30 mm and < 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 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 month since delivery, abortion, or lactation before start of Treatment)
- Hypersensitivity to any ingredient of the study drug
- Any condition requiring immediate blood transfusion
- Laboratory values outside inclusion range before randomization and considered as clinically relevant.
- 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

Trial Summary

Enrollment Goal
93
Trial Dates
black-arrow
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

Tianjin Medical University General Hospital

Tianjin, China, 300052

Status
Completed
 
Locations

Beijing Tiantan Hospital, Captial Medical University

Beijing, China, 100050

Status
Completed
 
Locations

Clinical Neurosciences Solutions, Inc DBA CNS Healthcare

Memphis, United States, 38119

Status
Completed
 
Locations

Eastern Carolina Women's Center

New Bern, United States, 28562

Status
Completed
 
Locations

Unified Women's Clinical Research - Morehead City

Morehead City, United States, 28557

Status
Completed
 
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
 
Locations

Atlanta Women's Research Institute, Inc. - Alpharetta

Atlanta, United States, 30342

Status
Completed
 
Locations

Medisense, Inc.

Atlanta, United States, 30363

Status
Completed
 
Locations

GTC Research

Shawnee, United States, 66218

Status
Completed
 
Locations

ONCOVA Clinical Research, Inc.

Saint Cloud, United States, 34769

Status
Completed
 
Locations

PharmaSite Research, Inc.

Baltimore, United States, 21208

Status
Completed
 
Locations

Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare

Jacksonville, United States, 32256

Status
Completed
 
Locations

One Health Research Clinic

Norcross, United States, 30093

Status
Completed
 
Locations

Beijing Hospital of Traditional Chinese Medicine

Beijing, China, 100010

Status
Completed
 
Locations

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, China, 030001

Status
Completed
 
Locations

General Hospital of Ningxia Medical University

Yinchuan, China, 750004

Status
Completed
 
Locations

Texas Health Care, PLLC

Ft. Worth, United States, 76104

Status
Completed
 
Locations

Agile Clinical Research Trials, LLC

Atlanta, United States, 30328

Status
Completed
 
Locations

Sweet Hope Research Specialty, Inc. - Hialeah

Hialeah, United States, 33016

Status
Terminated
 
Locations

The Second Affliated Hospital of Wenzhou Medicial University

Wenzhou, China, 325000

Status
Completed
 
Locations

Shengjing Hospital of China Medical University

Shenyang, China, 110022

Status
Completed
 
Locations

900th Hospital of Joint Logistics Support Force

Fuzhou, China, 350025

Status
Completed
 
Locations

Nanjing Maternity and Child Health Care Hospital

Nanjing, China, 210004

Status
Completed
 
Locations

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

Nanjing, China, 210008

Status
Completed
 
Locations

Wuhan Tongji Reproductive Medicine Hospital

Wuhan, China, 430013

Status
Completed
 
Locations

The First Hospital of Jilin University

Changchun, China, 130000

Status
Completed
 
Locations

Medical University of South Carolina

Charleston, United States, 29425

Status
Completed
 
Locations

Axcess Medical Research, LLC

Loxahatchee, United States, 33470

Status
Completed
 
Locations

Accelerated Enrollment Solutions a business of PPD

Orlando, United States, 32808

Status
Completed
 
Locations

Peking University First Hospital

Beijing, China, 100034

Status
Completed
 
Locations

The First Affiliated Hospital of Dalian Medical University

Dalian, China, 116011

Status
Completed
 
Locations

Hainan General Hospital

Haikou, China, 570311

Status
Completed
 
Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, China, 310006

Status
Completed
 
Locations

Sir Run Run Shaw Hospital, Zhejiang University School of Med

Hangzhou, China, 310016

Status
Completed
 
Locations

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China, 510630

Status
Completed
 
Locations

The Second Affiliated Hospital of Nanchang University

Nanchang, China, 330006

Status
Completed
 
Locations

Jiangxi Maternal and Child Health Hospital

Nanchang, China, 330006

Status
Completed
 
Locations

Omni Fertility and Laser Institute

Shreveport, United States, 71118

Status
Completed
 
Locations

Helix Biomedics, LLC

Boynton Beach, United States, 33435

Status
Completed
 
Locations

Core Healthcare Group

Cerritos, United States, 90703

Status
Completed
 
Locations

Synexus Research, LLC

Richmond, United States, 23226

Status
Completed
 
Locations

The First Affiliated Hospital of Xinjiang Medical University

Urumqi, China, 830054

Status
Completed
 
Locations

Shanghai East Hospital Affiated to Tongji University

Shanghai, China, 200123

Status
Completed
 
Locations

SUNY Downstate Medical Center

Brooklyn, United States, 11203

Status
Completed
 
Locations

Biopharma Informatic, Inc.

Houston, United States, 77043

Status
Completed
 
Locations

Carolinas Healthcare System

Charlotte, United States, 28204

Status
Completed
 
Locations

Hospital for Active Treatment - Prof.Paraskev Stoyanov AD

Lovech, Bulgaria, 5500

Status
Completed
 
Locations

MHAT Dr. Bratan Shukerov AD

Smolyan, Bulgaria, 4700

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD

Gabrovo, Bulgaria, 5300

Status
Completed
 
Locations

MHAT for Women's Health - Nadezhda OOD

Sofia, Bulgaria, 1330

Status
Completed
 
Locations

Chattanooga Medical Research, LLC

Chattanooga, United States, 37404

Status
Completed
 
Locations

Houston Center for Clinical Research, LLC

Sugarland, United States, 77479

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35294-0026

Status
Completed
 
Locations

Dr. Victoria Garcia & Associates, LLC Doral Medical Research

Doral, United States, 33166

Status
Completed
 
Locations

Discovery Clinical Research

Plantation, United States, 33324

Status
Completed
 
Locations

National Research Institute - Los Angeles

Los Angeles, United States, 90057

Status
Completed
 
Locations

Georgia Center For Women

Atlanta, United States, 30312

Status
Completed
 
Locations

The Center for Clinical Trials, Inc.

Houston, United States, 77082

Status
Completed
 
Locations

South Florida Medical Research

Aventura, United States, 33180

Status
Completed
 
Locations

Millennium Clinical Trials, LLC

Arlington, United States, 22207

Status
Completed
 
Locations

Main Line Fertility Center

Bryn Mawr, United States, 19010

Status
Completed
 
Locations

California Center for Clinical Research

Arcadia, United States, 91007

Status
Completed
 
Locations

Dr L Reynders Practice

Lyttelton Manor, South Africa, 0141

Status
Completed
 
Locations

Umhlanga Medical Centre

Durban, South Africa, 4319

Status
Completed
 
Locations

Wilgeheuwel Hospital

Roodepoort, South Africa, 1724

Status
Completed
 
Locations

Ethekwini Hospital & Heart Centre

Durban, South Africa

Status
Completed
 
Locations

Soukroma gynekologicka ambulance

Fulnek, Czech Republic, 74245

Status
Completed
 
Locations

MUDr. Ivana Salamonova s.r.o.

Vysoke Myto, Czech Republic, 566 01

Status
Completed
 
Locations

Gynekologie Studentsky dum s.r.o.

Praha 6, Czech Republic, 160 00

Status
Completed
 
Locations

Gynekologie MEDA s.r.o.

Brno, Czech Republic, 602 00

Status
Completed
 
Locations

Hillel Yaffe Medical Center

Hadera, Israel, 3810101

Status
Completed
 
Locations

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

Status
Completed
 
Locations

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710004

Status
Completed
 
Locations

1st Affiliated hospital of Soochow University

Suzhou, China, 215006

Status
Completed
 
Locations

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Status
Completed
 
Locations

P3 Research

Tauranga, New Zealand, 3110

Status
Completed
 
Locations

P3 Research Ltd Hawkes Bay

Hawkes Bay, New Zealand, 4130

Status
Completed
 
Locations

Family Medicine Clinic

Georgetown, United States, 78626

Status
Completed
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel, 3436212

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Clalit Health Services through HaEmek Medical Center

Afula, Israel, 1834111

Status
Completed
 
Locations

AVIVA Research

Escondido, United States, 92025

Status
Completed
 
Locations

Advantia Health, LLC Obstetrics & Gynecology Assoc.

Silver Spring, United States, 20910

Status
Completed
 
Locations

Simmonds, Martin and Helmbrecht

Gaithersburg, United States, 20878

Status
Completed
 
Locations

Paramount Research Solutions-Nashville

Nashville, United States, 37203

Status
Completed
 
Locations

Zhongda Hospital Southeast University

Nanjing, China, 210009

Status
Completed
 
Locations

University Hospital Kebangsaan Malaysia

Kuala Lumpur, Malaysia, 56000

Status
Completed
 
Locations

Hospital Wanita dan Kanak-Kanak Sabah

Sabah, Malaysia, 88996

Status
Completed
 
Locations

Sarawak General Hospital

Sarawak, Malaysia, 93400

Status
Completed
 
Locations

Ideal Clinical Research

Aventura, United States, 33180

Status
Completed
 
Locations

Fusion Clinical Research of Spartanburg, LLC

Spartanburg, United States, 29301

Status
Completed
 
Locations

Boai Hospital of Zhongshan

Zhongshan, China

Status
Completed
 
Locations

Harbor - UCLA Medical Center

Torrance, United States, 90509-2910

Status
Completed
 
Locations

Ocean Blue Medical Research Center, Inc.

Miami Springs, United States, 33166

Status
Completed
 
Locations

Guangzhou Women and Children's Medical Center

Guangzhou, China, 510623

Status
Completed
 
Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, China, 100050

Status
Completed
 
Locations

Fellows Research Alliance - Savannah

Savannah, United States, 31406

Status
Completed
 
Locations

Wake Research, Inc.

Raleigh, United States, 27612

Status
Completed
 
Locations

Fellows Research Alliance, Inc.

Bluffton, United States, 29910

Status
Completed
 
Locations

Willowbend Health & Wellness Associates

Frisco, United States, 75035

Status
Completed
 
Locations

Altus Research

Lake Worth, United States, 33461

Status
Completed
 
Locations

Paramount Research Solutions-College Park

College Park, United States, 30349

Status
Completed
 
Locations

Centex Studies, Inc.

Houston, United States, 77058

Status
Completed
 

Trial Design