Study Stopped
Due to a change in the development program, the study was closed prematurely.
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
2 other identifiers
interventional
93
9 countries
103
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2018
Typical duration for phase_3
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2018
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedStudy Start
First participant enrolled
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2019
CompletedResults Posted
Study results publicly available
June 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2022
CompletedMay 3, 2023
April 1, 2023
1.4 years
January 5, 2018
March 23, 2021
April 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Amenorrhea
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
The last 28 days of treatment period 1
Secondary Outcomes (6)
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
The last 28 days of treatment period 1 and treatment period 2
Time to Onset of Amenorrhea
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Time to Onset of Controlled Bleeding
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Number of Participants With Absence of Bleeding (Spotting Allowed)
The last 28 days of treatment period 1 and treatment period 2
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Up to 2 weeks after end of treatment
- +1 more secondary outcomes
Study Arms (4)
Vilaprisan (A1)
EXPERIMENTALVilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan (A2)
EXPERIMENTALVilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Placebo+Vilaprisan (B1)
EXPERIMENTALPlacebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan+Placebo (B2)
EXPERIMENTALVilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Interventions
2 mg of Vilaprisan once daily up to 2 x 12 weeks
Matching placebo was administered to group B1 and B2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (103)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0026, United States
California Center for Clinical Research
Arcadia, California, 91007, United States
Core Healthcare Group
Cerritos, California, 90703, United States
AVIVA Research
Escondido, California, 92025, United States
National Research Institute - Los Angeles
Los Angeles, California, 90057, United States
Harbor - UCLA Medical Center
Torrance, California, 90509-2910, United States
Ideal Clinical Research
Aventura, Florida, 33180, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Helix Biomedics, LLC
Boynton Beach, Florida, 33435, United States
Dr. Victoria Garcia & Associates, LLC Doral Medical Research
Doral, Florida, 33166, United States
Sweet Hope Research Specialty, Inc. - Hialeah
Hialeah, Florida, 33016, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
Jacksonville, Florida, 32256, United States
Altus Research
Lake Worth, Florida, 33461, United States
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, 33470, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166, United States
Accelerated Enrollment Solutions a business of PPD
Orlando, Florida, 32808, United States
Discovery Clinical Research
Plantation, Florida, 33324, United States
ONCOVA Clinical Research, Inc.
Saint Cloud, Florida, 34769, United States
Georgia Center For Women
Atlanta, Georgia, 30312, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
Atlanta Women's Research Institute, Inc. - Alpharetta
Atlanta, Georgia, 30342, United States
Medisense, Inc.
Atlanta, Georgia, 30363, United States
Paramount Research Solutions-College Park
College Park, Georgia, 30349, United States
One Health Research Clinic
Norcross, Georgia, 30093, United States
Fellows Research Alliance - Savannah
Savannah, Georgia, 31406, United States
GTC Research
Shawnee Mission, Kansas, 66218, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118, United States
PharmaSite Research, Inc.
Baltimore, Maryland, 21208, United States
Simmonds, Martin and Helmbrecht
Gaithersburg, Maryland, 20878, United States
Advantia Health, LLC Obstetrics & Gynecology Assoc.
Silver Spring, Maryland, 20910, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28204, United States
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, 28557, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Fellows Research Alliance, Inc.
Bluffton, South Carolina, 29910, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Fusion Clinical Research of Spartanburg, LLC
Spartanburg, South Carolina, 29301, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
Memphis, Tennessee, 38119, United States
Paramount Research Solutions-Nashville
Nashville, Tennessee, 37203, United States
Texas Health Care, PLLC
Fort Worth, Texas, 76104, United States
Willowbend Health & Wellness Associates
Frisco, Texas, 75035, United States
Family Medicine Clinic
Georgetown, Texas, 78626, United States
Biopharma Informatic, Inc.
Houston, Texas, 77043, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
The Center for Clinical Trials, Inc.
Houston, Texas, 77082, United States
Houston Center for Clinical Research, LLC
Sugar Land, Texas, 77479, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, 22207, United States
Synexus Research, LLC
Richmond, Virginia, 23226, United States
Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
Gabrovo, 5300, Bulgaria
Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
Lovech, 5500, Bulgaria
MHAT Dr. Bratan Shukerov AD
Smolyan, 4700, Bulgaria
MHAT for Women's Health - Nadezhda OOD
Sofia, 1330, Bulgaria
900th Hospital of Joint Logistics Support Force
Fuzhou, Fujian, 350025, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
Boai Hospital of Zhongshan
Zhongshan, Guangdong, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Wuhan Tongji Reproductive Medicine Hospital
Wuhan, Hubei, 430013, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
1st Affiliated hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110022, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
Sir Run Run Shaw Hospital, Zhejiang University School of Med
Hangzhou, Zhejiang, 310016, China
The Second Affliated Hospital of Wenzhou Medicial University
Wenzhou, Zhejiang, 325000, China
Beijing Hospital of Traditional Chinese Medicine
Beijing, 100010, China
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Beijing Tiantan Hospital, Captial Medical University
Beijing, 100050, China
Shanghai East Hospital Affiated to Tongji University
Shanghai, 200123, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Gynekologie MEDA s.r.o.
Brno, 602 00, Czechia
Soukroma gynekologicka ambulance
Fulnek, 74245, Czechia
Gynekologie Studentsky dum s.r.o.
Prague, 160 00, Czechia
MUDr. Ivana Salamonova s.r.o.
Vysoké Mýto, 566 01, Czechia
Clalit Health Services through HaEmek Medical Center
Afula, 1834111, Israel
Hillel Yaffe Medical Center
Hadera, 3810101, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
University Hospital Kebangsaan Malaysia
Kuala Lumpur, 56000, Malaysia
Hospital Wanita dan Kanak-Kanak Sabah
Sabak Bernam, 88996, Malaysia
Sarawak General Hospital
Sarawak, 93400, Malaysia
P3 Research Ltd Hawkes Bay
Hawkes Bay, 4130, New Zealand
P3 Research
Tauranga, 3110, New Zealand
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Dr L Reynders Practice
Lyttelton Manor, Gauteng, 0141, South Africa
Wilgeheuwel Hospital
Roodepoort, Gauteng, 1724, South Africa
Umhlanga Medical Centre
Durban, KwaZulu-Natal, 4319, South Africa
Ethekwini Hospital & Heart Centre
Durban, KwaZulu-Natal, South Africa
Related Publications (1)
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.
PMID: 37437885DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinding will be applied to Treatment Groups A1, B1, and B2; Treatment Group A2 will be open-label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2018
First Posted
January 17, 2018
Study Start
January 17, 2018
Primary Completion
June 9, 2019
Study Completion
April 6, 2022
Last Updated
May 3, 2023
Results First Posted
June 11, 2021
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.