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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
  • Lovech, Bulgaria, 5500
    • Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
  • Smolyan, Bulgaria, 4700
    • MHAT Dr. Bratan Shukerov AD
  • Sofia, Bulgaria, 1330
    • MHAT for Women's Health - Nadezhda OOD
• China
  • Beijing, China, 100010
    • Beijing Hospital of Traditional Chinese Medicine
  • Beijing, China, 100050
    • Beijing Tiantan Hospital, Captial Medical University
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital, Capital Medical University
  • Shanghai, China, 200123
    • Shanghai East Hospital Affiated to Tongji University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • 900TH Hospital of Joint Logistics Support Force
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women And Children's Medical Center
    • Zhongshan, Guangdong, China
      • Boai Hospital of Zhongshan
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hubei
    • Wuhan, Hubei, China, 430013
      • Wuhan Tongji Reproductive Medicine Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital
    • Suzhou, Jiangsu, China, 215006
      • 1st Affiliated hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Maternal and Child Health Hospital
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The first affiliated hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital of China Medical University
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710004
      • Second Affiliated Hospital of Xi'an JiaoTong University
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The Second Affiliated Hospital of Shanxi Medical University
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • The first affiliated hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital School of Medicine Zhejiang University
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Med
    • Wenzhou, Zhejiang, China, 325000
      • The Second Affliated Hospital of Wenzhou Medicial University
• Czechia
  • Brno, Czechia, 602 00
    • Gynekologie MEDA s.r.o.
  • Fulnek, Czechia, 74245
    • Soukroma gynekologicka ambulance
  • Praha 6, Czechia, 160 00
    • Gynekologie Studentsky dum s.r.o.
  • Vysoke Myto, Czechia, 566 01
    • MUDr. Ivana Salamonova s.r.o.
• Israel
  • Afula, Israel, 1834111
    • Clalit Health Services through HaEmek Medical Center
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
• Malaysia
  • Kuala Lumpur, Malaysia, 56000
    • University Hospital Kebangsaan Malaysia
  • Sabah, Malaysia, 88996
    • Hospital Wanita Dan Kanak-kanak Sabah
  • Sarawak, Malaysia, 93400
    • Sarawak General Hospital
• New Zealand
  • Hawkes Bay, New Zealand, 4130
    • P3 Research Ltd Hawkes Bay
  • Tauranga, New Zealand, 3110
    • P3 Research
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
• South Africa
  • Gauteng
    • Lyttelton Manor, Gauteng, South Africa, 0141
      • Dr L Reynders Practice
    • Roodepoort, Gauteng, South Africa, 1724
      • Wilgeheuwel Hospital
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4319
      • Umhlanga Medical Centre
    • Durban, Kwazulu-Natal, South Africa
      • Ethekwini Hospital & Heart Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0026
      • University of Alabama at Birmingham
  • California
    • Arcadia, California, United States, 91007
      • California Center for Clinical Research
    • Cerritos, California, United States, 90703
      • Core Healthcare Group
    • Escondido, California, United States, 92025
      • AVIVA Research
    • Los Angeles, California, United States, 90057
      • National Research Institute - Los Angeles
    • Torrance, California, United States, 90509-2910
      • Harbor - UCLA Medical Center
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Aventura, Florida, United States, 33180
      • Ideal Clinical Research
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics, LLC
    • Doral, Florida, United States, 33166
      • Dr. Victoria Garcia & Associates, LLC Doral Medical Research
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc. - Hialeah
    • Jacksonville, Florida, United States, 32256
      • Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Loxahatchee Groves, Florida, United States, 33470
      • Axcess Medical Research, LLC
    • Miami Springs, Florida, United States, 33166
      • Ocean Blue Medical Research Center, Inc.
    • Orlando, Florida, United States, 32808
      • Accelerated Enrollment Solutions a business of PPD
    • Plantation, Florida, United States, 33324
      • Discovery Clinical Research
    • Saint Cloud, Florida, United States, 34769
      • ONCOVA Clinical Research, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
    • Atlanta, Georgia, United States, 30312
      • Georgia Center For Women
    • Atlanta, Georgia, United States, 30363
      • Medisense, Inc.
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Research Institute, Inc. - Alpharetta
    • College Park, Georgia, United States, 30349
      • Paramount Research Solutions-College Park
    • Norcross, Georgia, United States, 30093
      • One Health Research Clinic
    • Savannah, Georgia, United States, 31406
      • Fellows Research Alliance - Savannah
  • Kansas
    • Shawnee Mission, Kansas, United States, 66218
      • Gtc Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71118
      • Omni Fertility and Laser Institute
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
    • Gaithersburg, Maryland, United States, 20878
      • Simmonds, Martin and Helmbrecht
    • Silver Spring, Maryland, United States, 20910
      • Advantia Health, LLC Obstetrics & Gynecology Assoc.
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Healthcare System
    • Morehead City, North Carolina, United States, 28557
      • Unified Women's Clinical Research - Morehead City
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center
    • Raleigh, North Carolina, United States, 27612
      • Wake Research, Inc.
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Main Line Fertility Center
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Of Philadelphia, Llc
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Fellows Research Alliance, Inc.
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Spartanburg, South Carolina, United States, 29301
      • Fusion Clinical Research of Spartanburg, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, Llc
    • Memphis, Tennessee, United States, 38119
      • Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
    • Nashville, Tennessee, United States, 37203
      • Paramount Research Solutions-Nashville
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Health Care, PLLC
    • Frisco, Texas, United States, 75035
      • Willowbend Health & Wellness Associates
    • Georgetown, Texas, United States, 78626
      • Family Medicine Clinic
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, Inc.
    • Houston, Texas, United States, 77082
      • The Center for Clinical Trials, Inc.
    • Sugar Land, Texas, United States, 77479
      • Houston Center for Clinical Research, LLC
  • Virginia
    • Arlington, Virginia, United States, 22207
      • Millennium Clinical Trials, LLC
    • Richmond, Virginia, United States, 23226
      • Synexus Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 ≥ 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily up to 2 x 12 weeks; Drug: Placebo; Matching placebo was administered to group B1 and B2.
Experimental: Vilaprisan (A2); Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily up to 2 x 12 weeks
Experimental: 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.	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily up to 2 x 12 weeks; Drug: Placebo; Matching placebo was administered to group B1 and B2.
Experimental: 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.	Drug: Vilaprisan (BAY1002670); 2 mg of Vilaprisan once daily up to 2 x 12 weeks; Drug: Placebo; Matching placebo was administered to group B1 and B2.

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 measured by the alkaline hematin (AH) method.	The last 28 days of treatment period 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Uterine Fibroid Daily Bleeding Diary (UF-DBD).	The last 28 days of treatment period 1 and treatment period 2
Number of Participants With Heavy Menstrual Bleeding (HMB) Response	HMB response was defined as MBL <80 mL during the last 28 days of treatment and >50% reduction from baseline based on AH-method.	The last 28 days of treatment period 1 and treatment period 2
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 based on AH-method.	In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)	Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.	Up to 2 weeks after end of treatment
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.	Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years])

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Actual): June 9, 2019
• Study Completion (Actual): April 6, 2022

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): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

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: 15787; 2017-002997-38 (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.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.

Drug and device information, study documents

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