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 4)
A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
2 other identifiers
interventional
103
5 countries
87
Brief Summary
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
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
87 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 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2019
CompletedResults Posted
Study results publicly available
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJune 30, 2022
June 1, 2022
1.2 years
January 5, 2018
March 24, 2021
June 29, 2022
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. The evaluation of MBL was based on 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 by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Up to 36 weeks
- +1 more secondary outcomes
Study Arms (3)
Vilaprisan (A1)
EXPERIMENTALVilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Placebo+Vilaprisan (B1)
EXPERIMENTALPlacebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Vilaprisan+Placebo (B2)
EXPERIMENTALVilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Interventions
Orally, coated tablet 2 mg, once daily
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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (87)
Clearview Medical Research, LLC
Canyon Country, California, 91351, United States
Diagnamics, Inc.
Encinitas, California, 92024, United States
National Research Institute
Huntington Park, California, 90255, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
West Coast OB/GYN Associates
La Mesa, California, 91942, United States
National Research Institute
Panorama City, California, 91402, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Vital Pharma Research
Hialeah, Florida, 33016, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
South Florida Clinical Research Institute
Margate, Florida, 33073, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
Genoma Research Group, Inc.
Miami, Florida, 33165, United States
Florida Research Center, Inc.
Miami, Florida, 33174, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Vista Health Research
Miami, Florida, 33176, United States
Palmetto Professional Research
Miami, Florida, 33186, United States
Savin Medical Group LLC
Miami Lakes, Florida, 33014, United States
A Premier Medical Research of Florida, LLC
Orange City, Florida, 32763, United States
Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
Orlando, Florida, 32801, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
DMI Research
Pinellas Park, Florida, 33782, United States
Physician Care Clinical Research
Sarasota, Florida, 34239, United States
Journey Medical Research
Snellville, Georgia, 30078, United States
Women's Healthcare Associates, PA
Idaho Falls, Idaho, 83404, United States
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Unified Women's Clinical Research
Greensboro, North Carolina, 27408, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Unified Women's Clinical Research / Ocala, FL
Winston-Salem, North Carolina, 27103, United States
Oregon Health and Science University
Portland, Oregon, 97239-3011, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vista Clinical Research
Columbia, South Carolina, 29201, United States
Chattanooga Women for Women
Hixson, Tennessee, 37343, United States
Women Partners in Health Obstetrics & Gynecology (OB/GYN)
Austin, Texas, 78705, United States
Gadolin Research
Beaumont, Texas, 77702, United States
Discovery Clinical Trials
Dallas, Texas, 75231, United States
Advances in Health, Inc.
Houston, Texas, 77030, United States
Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Center of Reproductive Medicine
Webster, Texas, 77598, United States
Tidewater Physicians for Women
Norfolk, Virginia, 23502, United States
Seattle Clinical Research Center
Seattle, Washington, 98105, United States
GynPorCentrum s.r.o.
Krnov, 794 01, Czechia
Gynekologie MUDr. Jaromir Karban s.r.o
Neratovice, 277 11, Czechia
Privatni gynekologicko-porodnicka ordinace
Prague, 16000, Czechia
GYNEVI s.r.o.
Rokycany, 337 01, Czechia
Gynekologicka ambulance - Zabreh na Morave
Zábřeh, 78901, Czechia
Funabashi Municipal Medical Center
Funabashi, Chiba, 273-8588, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Chiba, 277-0871, Japan
Matsudo City General Hospital
Matsudo, Chiba, 270-2296, Japan
Hashimoto Clinic
Sapporo, Hokkaido, 004-0052, Japan
Ena Odori Clinic
Sapporo, Hokkaido, 060-0001, Japan
Tokeidai Memorial Clinic
Sapporo, Hokkaido, 060-0031, Japan
Yoshio Clinic
Sapporo, Hokkaido, 064-0808, Japan
Kosumo Clinic
Kako-gun, Hyōgo, 675-1115, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
Asahi-Clinic.
Takamatsu, Kagawa-ken, 760-0076, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041, Japan
Kyoto city Hospital
Nakagyo-ku, Kyoto, 604-8845, Japan
Medical Topia Soka Hospital
Sōka, Saitama, 340-0028, Japan
Omi Medical Center
Kusatsu, Shiga, 525-8585, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, 810-0001, Japan
Unoki Clinic
Kagoshima, 892-0826, Japan
Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine
Kagoshima, 892-0845, Japan
Four Seasons Ladies' Clinic
Kumamoto, 860-0846, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520, Japan
Ijinkai Takeda General Hospital
Kyoto, 601-1495, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026, Japan
Gokeikai Osaka Kaisei Hospital
Osaka, 532-0003, Japan
Osaka City Hospital Organization Osaka City General Hospital
Osaka, 534-0021, Japan
Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi
Osaka, 542-0086, Japan
Altai State Medical University
Barnaul, 656038, Russia
Maternity Hospital, 17
Saint Petersburg, 192174, Russia
Med Estetic Center
Saint Petersburg, 192177, Russia
"Granti-Med"
Saint Petersburg, 198329, Russia
Scien. Res. Institute of Obsterics, Gyn. & Reproduction
Saint Petersburg, 199034, Russia
Close Joint Stock Company "Medical Company IDK"
Samara, 443067, Russia
Smolensk State Medical University
Smolensk, 214019, Russia
Chernivtsi Regional Perinatal Center
Chernivtsi, 58001, Ukraine
Vinnytsia City Clinical Maternity Hospital No 2
Vinnytsia, 21001, Ukraine
Zaporizhzhia Regional Clinical Hospital
Zaporizhzhya, 69103, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
* The trial was terminated earlier than planned. It was sufficiently advanced to allow for meaningful analysis. * In many subjects, follow up phase was longer than the planned one. * Safety evaluations were not limited to the planned timepoints.
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
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- 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 24, 2018
Primary Completion
March 23, 2019
Study Completion
June 30, 2021
Last Updated
June 30, 2022
Results First Posted
April 30, 2021
Record last verified: 2022-06
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.