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

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

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Vilaprisan (BAY1002670); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Krnov, Czechia, 794 01
    • GynPorCentrum s.r.o.
  • Neratovice, Czechia, 277 11
    • Gynekologie MUDr. Jaromir Karban s.r.o
  • Praha, Czechia, 16000
    • Privatni gynekologicko-porodnicka ordinace
  • Rokycany, Czechia, 337 01
    • GYNEVI s.r.o.
  • Zabreh Na Morave, Czechia, 78901
    • Gynekologicka ambulance - Zabreh na Morave
• Japan
  • Fukuoka, Japan, 810-0001
    • Saiseikai Fukuoka General Hospital
  • Kagoshima, Japan, 892-0826
    • Unoki Clinic
  • Kagoshima, Japan, 892-0845
    • Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Kumamoto, Japan, 860-0846
    • Four Seasons Ladies' Clinic
  • Kyoto, Japan, 601-1495
    • Ijinkai Takeda General Hospital
  • Kyoto, Japan, 602-8026
    • Japanese Red Cross Kyoto Daini Hospital
  • Osaka, Japan, 532-0003
    • Gokeikai Osaka Kaisei Hospital
  • Osaka, Japan, 534-0021
    • Osaka City Hospital Organization Osaka City General Hospital
  • Osaka, Japan, 542-0086
    • Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi
  • Chiba
    • Funabashi, Chiba, Japan, 273-8588
      • Funabashi Municipal Medical Center
    • Kashiwa, Chiba, Japan, 277-0871
      • Tsujinaka Hospital Kashiwanoha
    • Matsudo, Chiba, Japan, 270-2296
      • Matsudo City General Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 004-0052
      • Hashimoto Clinic
    • Sapporo, Hokkaido, Japan, 060-0001
      • Ena Odori Clinic
    • Sapporo, Hokkaido, Japan, 064-0808
      • Yoshio Clinic
    • Sapporo, Hokkaido, Japan, 060-0031
      • Tokeidai Memorial Clinic
  • Hyogo
    • Kako-gun, Hyogo, Japan, 675-1115
      • Kosumo Clinic
    • Kobe, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Kagawa
    • Takamatsu, Kagawa, Japan, 760-8557
      • Kagawa Prefectural Central Hospital
    • Takamatsu, Kagawa, Japan, 760-0017
      • Takamatsu Red Cross Hospital
    • Takamatsu, Kagawa, Japan, 760-0076
      • Asahi-Clinic.
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-0041
      • Shonan Fujisawa Tokushukai Hospital
  • Kyoto
    • Nakagyo-ku, Kyoto, Japan, 604-8845
      • Kyoto City Hospital
  • Saitama
    • Soka, Saitama, Japan, 340-0028
      • Medical Topia Soka Hospital
  • Shiga
    • Kusatsu, Shiga, Japan, 525-8585
      • Omi Medical Center
• Russian Federation
  • Barnaul, Russian Federation, 656038
    • Altai State Medical University
  • Saint-Petersburg, Russian Federation, 192174
    • Maternity Hospital, 17
  • Samara, Russian Federation, 443067
    • Close Joint Stock Company "Medical Company IDK"
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical University
  • St. Petersburg, Russian Federation, 198329
    • "Granti-Med"
  • St. Petersburg, Russian Federation, 199034
    • Scien. Res. Institute of Obsterics, Gyn. & Reproduction
  • St. Petersburg, Russian Federation, 192177
    • Med Estetic Center
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Chernivtsi Regional Perinatal Center
  • Vinnytsia, Ukraine, 21001
    • Vinnytsia City Clinical Maternity Hospital No 2
  • Zaporizhzhya, Ukraine, 69103
    • Zaporizhzhia Regional Clinical Hospital
• United States
  • California
    • Canyon Country, California, United States, 91351
      • Clearview Medical Research, LLC
    • Encinitas, California, United States, 92024
      • Diagnamics, Inc.
    • Huntington Park, California, United States, 90255
      • National Research Institute
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • La Mesa, California, United States, 91942
      • West Coast OB/GYN Associates
    • Panorama City, California, United States, 91402
      • National Research Institute
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
  • Florida
    • Clearwater, Florida, United States, 33759
      • Women's Medical Research Group, LLC
    • Hialeah, Florida, United States, 33016
      • Vital Pharma Research
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research, Inc.
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Margate, Florida, United States, 33073
      • South Florida Clinical Research Institute
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC
    • Miami, Florida, United States, 33174
      • Florida Research Center, Inc.
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute, LLC
    • Miami, Florida, United States, 33176
      • Vista Health Research
    • Miami, Florida, United States, 33165
      • Genoma Research Group, Inc.
    • Miami, Florida, United States, 33186
      • Palmetto Professional Research
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group LLC
    • Orange City, Florida, United States, 32763
      • A Premier Medical Research of Florida, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research, LLC
    • Pinellas Park, Florida, United States, 33782
      • DMI Research
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Journey Medical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Women's Healthcare Associates, PA
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Unified Women's Clinical Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research / Ocala, FL
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Oregon Health and Science University
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Vista Clinical Research
  • Tennessee
    • Hixson, Tennessee, United States, 37343
      • Chattanooga Women for Women
  • Texas
    • Austin, Texas, United States, 78705
      • Women Partners in Health Obstetrics & Gynecology (OB/GYN)
    • Beaumont, Texas, United States, 77702
      • Gadolin Research
    • Dallas, Texas, United States, 75231
      • Discovery Clinical Trials
    • Houston, Texas, United States, 77030
      • Advances in Health, Inc.
    • San Antonio, Texas, United States, 78258
      • Discovery Clinical Trials
    • Webster, Texas, United States, 77598
      • Center of Reproductive Medicine
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vilaprisan (A1); Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.	Drug: Vilaprisan (BAY1002670); Orally, coated tablet 2 mg, once daily
Experimental: Placebo+Vilaprisan (B1); Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.	Drug: Vilaprisan (BAY1002670); Orally, coated tablet 2 mg, once daily; Drug: Placebo; Orally, coated tablet, once daily
Experimental: Vilaprisan+Placebo (B2); Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.	Drug: Vilaprisan (BAY1002670); Orally, coated tablet 2 mg, once daily; Drug: Placebo; Orally, coated tablet, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Heavy Menstrual Bleeding (HMB) Response	HMB was defined as MBL <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline (assessed by the AH method).	The last 28 days of treatment period 1 and treatment period 2
Time to Onset of Amenorrhea	Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was <2 mL (amenorrhea defined similar to primary endpoint and assessed by the AH method).	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Time to Onset of Controlled Bleeding	Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was <80.00 mL (assessed by the AH method).	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Number of Participants With Absence of Bleeding (Spotting Allowed)	Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the UF-DBD (Uterine Fibroid Daily Bleeding Diary).	The last 28 days of treatment period 1 and treatment period 2
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)	Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with atypia and endometrial polyps.	Up to 36 weeks
Change From Baseline of Endometrial Thickness	Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): March 23, 2019
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Heavy menstrual bleeding
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: 15790; 2016-003561-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No