Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
NCT ID: NCT03400943
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
93 participants
INTERVENTIONAL
2018-01-17
2022-04-06
Brief Summary
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The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Placebo
Matching placebo was administered to group B1 and B2.
Vilaprisan (A2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Placebo
Matching placebo was administered to group B1 and B2.
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Placebo
Matching placebo was administered to group B1 and B2.
Interventions
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Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Placebo
Matching placebo was administered to group B1 and B2.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Center for Clinical Research
Arcadia, California, United States
Core Healthcare Group
Cerritos, California, United States
AVIVA Research
Escondido, California, United States
National Research Institute - Los Angeles
Los Angeles, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
Ideal Clinical Research
Aventura, Florida, United States
South Florida Medical Research
Aventura, Florida, United States
Helix Biomedics, LLC
Boynton Beach, Florida, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
Doral, Florida, United States
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States
Accelerated Enrollment Solutions a business of PPD
Orlando, Florida, United States
Discovery Clinical Research
Plantation, Florida, United States
ONCOVA Clinical Research, Inc.
Saint Cloud, Florida, United States
Georgia Center For Women
Atlanta, Georgia, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Atlanta Women's Research Institute, Inc. - Alpharetta
Atlanta, Georgia, United States
Medisense, Inc.
Atlanta, Georgia, United States
Paramount Research Solutions-College Park
College Park, Georgia, United States
One Health Research Clinic
Norcross, Georgia, United States
Fellows Research Alliance - Savannah
Savannah, Georgia, United States
GTC Research
Shawnee Mission, Kansas, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States
PharmaSite Research, Inc.
Baltimore, Maryland, United States
Simmonds, Martin and Helmbrecht
Gaithersburg, Maryland, United States
Advantia Health, LLC Obstetrics & Gynecology Assoc.
Silver Spring, Maryland, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Wake Research, Inc.
Raleigh, North Carolina, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Fellows Research Alliance, Inc.
Bluffton, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Fusion Clinical Research of Spartanburg, LLC
Spartanburg, South Carolina, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
Memphis, Tennessee, United States
Paramount Research Solutions-Nashville
Nashville, Tennessee, United States
Texas Health Care, PLLC
Fort Worth, Texas, United States
Willowbend Health & Wellness Associates
Frisco, Texas, United States
Family Medicine Clinic
Georgetown, Texas, United States
Biopharma Informatic, Inc.
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
The Center for Clinical Trials, Inc.
Houston, Texas, United States
Houston Center for Clinical Research, LLC
Sugar Land, Texas, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, United States
Synexus Research, LLC
Richmond, Virginia, United States
Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
Gabrovo, , Bulgaria
Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
Lovech, , Bulgaria
MHAT Dr. Bratan Shukerov AD
Smolyan, , Bulgaria
MHAT for Women's Health - Nadezhda OOD
Sofia, , Bulgaria
900th Hospital of Joint Logistics Support Force
Fuzhou, Fujian, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Boai Hospital of Zhongshan
Zhongshan, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
Wuhan Tongji Reproductive Medicine Hospital
Wuhan, Hubei, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
1st Affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Med
Hangzhou, Zhejiang, China
The Second Affliated Hospital of Wenzhou Medicial University
Wenzhou, Zhejiang, China
Beijing Hospital of Traditional Chinese Medicine
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Tiantan Hospital, Captial Medical University
Beijing, , China
Shanghai East Hospital Affiated to Tongji University
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
Gynekologie MEDA s.r.o.
Brno, , Czechia
Soukroma gynekologicka ambulance
Fulnek, , Czechia
Gynekologie Studentsky dum s.r.o.
Prague, , Czechia
MUDr. Ivana Salamonova s.r.o.
Vysoké Mýto, , Czechia
Clalit Health Services through HaEmek Medical Center
Afula, , Israel
Hillel Yaffe Medical Center
Hadera, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
University Hospital Kebangsaan Malaysia
Kuala Lumpur, , Malaysia
Hospital Wanita dan Kanak-Kanak Sabah
Sabak Bernam, , Malaysia
Sarawak General Hospital
Sarawak, , Malaysia
P3 Research Ltd Hawkes Bay
Hawkes Bay, , New Zealand
P3 Research
Tauranga, , New Zealand
KK Women's and Children's Hospital
Singapore, , Singapore
Dr L Reynders Practice
Lyttelton Manor, Gauteng, South Africa
Wilgeheuwel Hospital
Roodepoort, Gauteng, South Africa
Umhlanga Medical Centre
Durban, KwaZulu-Natal, South Africa
Ethekwini Hospital & Heart Centre
Durban, KwaZulu-Natal, South Africa
Countries
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References
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Al-Hendy A, Zhou YF, Faustmann T, Groettrup-Wolfers E, Laapas K, Parke S, Seitz C. Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial. F S Sci. 2023 Nov;4(4):317-326. doi: 10.1016/j.xfss.2023.06.003. Epub 2023 Jul 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
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Other Identifiers
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2017-002997-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15787
Identifier Type: -
Identifier Source: org_study_id
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