A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 5)

A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 766
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Pty Ltd
    • Kanwal, New South Wales, Australia, 2259
      • Paratus Clinical Wyong Complex
    • Sydney, New South Wales, Australia, 2000
      • Women's Health and Research Institute of Australia-WHRIA
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Greenslopes Private Hospital
• Austria
  • Wien, Austria, 1090
    • Universitätsklinikum AKH Wien
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
  • Vorarlberg
    • Bregenz, Vorarlberg, Austria, 6900
      • Landeskrankenhaus Bregenz
• Belgium
  • Bruxelles - Brussel, Belgium, 1200
    • CU Saint-Luc/UZ St-Luc
  • Bruxelles - Brussel, Belgium, 1000
    • CHU Saint-Pierre/UMC Sint-Pieter
  • La Louviere, Belgium, 7100
    • CHU de Tivoli
  • Liege, Belgium, 4000
    • CHR de la Citadelle - Department of Gynaecology & Obstetrics
  • Tienen, Belgium, 3300
    • Femicare vzw
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Jan Palfijn Gent
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • MHAT Blagoevgrad AD
  • Dobrich, Bulgaria, 9300
    • MHAT Dobrich
  • Dupnitsa, Bulgaria, 2600
    • MC Asklepii OOD
  • Panagyurishte, Bulgaria, 4500
    • Multiprofile Hospital for Active Treatment Uni Hospital OOD
  • Pleven, Bulgaria, 5800
    • MHAT Avis Medika
  • Sofia, Bulgaria, 1431
    • DCC Aleksandrovska
  • Sofia, Bulgaria, 1233
    • Spec. Hospital for Active Treatment of Oncological Diseases
  • Sofia, Bulgaria, 1606
    • Medical Center Panaceya
  • Stara Zagora, Bulgaria, 6000
    • MHAT Niamed
  • Varna, Bulgaria, 9000
    • SHOGAT Prof Dimitar Stamatov
  • Varna, Bulgaria, 9000
    • Multiprofile Hospital for Active Treatment Sv. Anna
• Canada
  • Quebec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Quebec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1S 2L6
    • Clinique Recherche en Sante des Femmes Inc.
  • British Columbia
    • Surrey, British Columbia, Canada, V3S 2N6
      • Ocean West Research Clinic Inc
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Strand Clinic
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • Ottawa Hospital-Riverside Campus
  • Quebec
    • Montreal, Quebec, Canada, H4P 2S4
      • Clinique ovo
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno
  • Ceske Budejovice, Czechia, 370 01
    • Gynekologicka ordinace - Ceske Budejovice
  • Olomouc, Czechia, 772 00
    • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • Pisek, Czechia, 39701
    • Centrum gynekologicke rehabilitace
  • Plzen, Czechia, 300 01
    • MUDr. Martina Maresova Rosenbergova, gynekologie
  • Tabor, Czechia, 39003
    • Dr. Smrhova-Kovacs
  • Trebon, Czechia, 379 01
    • MediGyn s.r.o.
  • Vsetin, Czechia, 755 01
    • GYNEKO spol. s r.o.
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital, Skejby
  • Hillerød, Denmark, 3400
    • Nordsjælland Hospital Hillerød
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
• Finland
  • Helsinki, Finland, 00029
    • HUS / Naistenklinikka
  • Helsinki, Finland, 00510
    • VL-Medi Oy
  • Kotka, Finland, 48210
    • Kymenlaakson keskussairaala
  • Kuopio, Finland, 70110
    • Lääkäriasema Cantti Oy
  • Oulu, Finland, 90100
    • Lääkärikeskus Gyneko
  • Turku, Finland, 20520
    • Turun yliopistollinen keskussairaala
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68165
      • Praxisklinik am Rosengarten
  • Nordrhein-Westfalen
    • Stolberg, Nordrhein-Westfalen, Germany, 52222
      • Frauenarztpraxis Dr. Wolfgang Clemens
  • Sachsen-Anhalt
    • Bernburg, Sachsen-Anhalt, Germany, 06406
      • Praxis f. Gynäkologie und Geburtshilfe
• Hungary
  • Baja, Hungary, 6500
    • Principal SMO Kft.
  • Bekescsaba, Hungary, 5600
    • Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
  • Budapest, Hungary, 1135
    • Tritonlife Robert Magankorhaz
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4028
    • NAP - Rendelo, Private Clinic
  • Debrecen, Hungary, 4024
    • Szent Anna szuleszeti-nogyogyaszati maganrendelo
  • Komarom, Hungary, 2900
    • Komaromi Selye Janos Korhaz
  • Nyiregyhaza, Hungary, 4400
    • SzSzBMK es EOK Josa Andras Oktatokorhaz
  • Szeged, Hungary, 6725
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
• Ireland
  • Westmeath
    • Mullingar, Westmeath, Ireland
      • Midland Regional Hospital
• Italy
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • A.O.U. Policlinico G.Rodolico-San Marco
    • Palermo, Sicilia, Italy, 90146
      • A.O. Ospedali Riuniti Villa Sofia-Cervello
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • A.O.U. Careggi
  • Veneto
    • Verona, Veneto, Italy, 37126
      • A.O.U.I. Verona
• Korea, Republic of
  • Busan, Korea, Republic of, 612-862
    • Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 135-081
    • CHA Gangnam Medical Center
  • Seoul, Korea, Republic of, 158-710
    • Ewha Womans University Hospital
  • Seoul, Korea, Republic of, 07441
    • KangNam Sacred Heart Hospital
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10326
      • Dongguk University Ilsan Hospital
    • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggido, Korea, Republic of, 443-721
      • Ajou University Hospital
• Lithuania
  • Kaunas, Lithuania, LT-51028
    • Jsc "Vakk"
  • Klaipeda, Lithuania, LT-93200
    • Klaipeda City Outpatient Clinic
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania, LT-01118
    • JSC Seimos gydytojas family medical center
  • Vilnius, Lithuania, LT-03225
    • JSC Gyvenk Silciau Medical Center Maxmeda
  • Vilnius, Lithuania, LT-05263
    • Private hospital and outpatient clinic "Kardiolita"
• Netherlands
  • Almere, Netherlands, 1315 RA
    • Flevoziekenhuis
  • Amsterdam, Netherlands, 1081 HV
    • VUmc
  • Rotterdam, Netherlands, 3079DZ
    • Maasstad Ziekenhuis | Neurology Department
• Norway
  • Fredrikstad, Norway, 1605
    • Kirkeparken Spesialistpraksis
  • Nesttun, Norway, 5221
    • Nesttun Spesialistpraksis AS
  • Oslo, Norway, 0161
    • Medicus Oslo AS
  • Stavanger, Norway, 4011
    • Stavanger Universitetssjukehus
  • Trondheim, Norway, 7014
    • Medicus AS
• Poland
  • Bialystok, Poland, 15-244
    • Prywatna Klinika Ginekologiczno-Poloznicza
  • Bialystok, Poland, 15-084
    • Tomaszewski Medical Center
  • Katowice, Poland, 40-156
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Katowice, Poland, 40-748
    • Vita Longa Sp. z o.o.
  • Krakow, Poland, 31-315
    • Medico Praktyka Lekarska
  • Lodz, Poland, 90-602
    • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Lublin, Poland, 20-093
    • Centrum Medyczne Chodzki
  • Lublin, Poland, 20-400
    • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • Lublin, Poland, 20-632
    • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
  • Szczecin, Poland, 70-483
    • VitroLive Sp. z o.o.
  • Warszawa, Poland, 02-679
    • Centrum Badawcze Wspolczesnej Terapii
  • Warszawa, Poland, 02-201
    • Nzoz Zieniewicz Medical
• Portugal
  • Braga, Portugal, 4710-243
    • Centro Clinico Academico - Braga
  • Coimbra, Portugal, 3000-075
    • CHUC - Hospitais da Universidade de Coimbra
  • Lisboa, Portugal, 1449-005
    • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
• Slovakia
  • Bratislava 2, Slovakia, 826 06
    • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Hlohovec, Slovakia, 920 01
    • ULMUS, s r.o.
  • Lucenec, Slovakia, 984 01
    • GA Lucenec s.r.o
  • Nitra, Slovakia, 949 01
    • Galipea s.r.o.
  • Nitra, Slovakia, 949 01
    • Gyncentrum Nitra s.r.o.
  • Velky Krtis, Slovakia, 990 01
    • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Sevilla, Spain, 41010
    • Ginemed
  • Sevilla, Spain, 41013
    • H Virgen del Rocio |Cardiology|AF|Stroke prevention
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Madrid
    • Aravaca, Madrid, Spain, 28023
      • Hospital Sanitas La Zarzuela
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto
  • Álava
    • Vitoria, Álava, Spain, 01009
      • Hospital Universitario de Álava - Sede Txagorritxu
• Sweden
  • Stockholm, Sweden, 182 88
    • Danderyds Sjukhus
  • Stockholm, Sweden, 118 83
    • Sodersjukhuset AB
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset i Solna
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital at Linkou
• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea & Westminster Hospital
  • London, United Kingdom, N18 1QX
    • North Middlesex University Hospital
  • London, United Kingdom, N19 5NF
    • Whittington Hospital
  • London, United Kingdom, W2 1NY
    • St Mary's Hospital (London)
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9NA
      • North Hampshire Hospital

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 at the time of Visit 1
• 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) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
• Use of an acceptable non-hormonal method of contraception
• An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

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 drugs
• 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 including
• Abuse of alcohol, drugs, or medicines (eg: laxatives)
• Undiagnosed abnormal genital bleeding
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A1: Vilaprisan (3/1 regimen); Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode	Drug: Vilaprisan (BAY1002670); Orally, 2 mg, once daily
Experimental: Group A2: Vilaprisan (6/2 regimen); Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes	Drug: Vilaprisan (BAY1002670); Orally, 2 mg, once daily
Experimental: Group A3/B (3/2 regimen); Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.	Drug: Vilaprisan (BAY1002670); Orally, 2 mg, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amenorrhea (yes/no)	Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days. For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.	At 3 months (at the end of treatment perid 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of menstrual blood loss	Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.	After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Number of bleeding days	From day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days.	After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Amenorrhea (yes/no)	Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.	At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
Absence of bleeding (spotting allowed)	Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary).	Up to 24 months
Time to onset of controlled bleeding	Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL.	Quarterly up to 24 months
HMB (Heavy Menstrual Bleeding) responder rate	Percentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]	By treatment period up to 24 months
Percent change in volume of largest fibroid compared to baseline	Measured by MRI (magnetic resonance imaging).	At baseline, at 12 months and at 24 months
Endometrial histology	E.g., benign endometrium, presence or absence of hyperplasia or malignancy	Up to 24 months
Endometrial thickness		Up to 24 months

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, 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): July 31, 2017
• Primary Completion (Actual): June 28, 2020
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• 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: 15789; 2016-002855-48 (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: No
• Studies a U.S. FDA-regulated device product: No