Study Stopped
Due to a change in the development program, the study was closed prematurely.
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
2 other identifiers
interventional
766
22 countries
135
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2017
Typical duration for phase_3
135 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
July 21, 2017
CompletedStudy Start
First participant enrolled
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2021
CompletedOctober 18, 2024
October 1, 2024
2.9 years
July 21, 2017
October 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Total volume of menstrual blood loss
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Number of bleeding days
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Amenorrhea (yes/no)
At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
Absence of bleeding (spotting allowed)
Up to 24 months
Time to onset of controlled bleeding
Quarterly up to 24 months
- +4 more secondary outcomes
Study Arms (3)
Group A1: Vilaprisan (3/1 regimen)
EXPERIMENTALOrally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Group A2: Vilaprisan (6/2 regimen)
EXPERIMENTALOrally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Group A3/B (3/2 regimen)
EXPERIMENTALOrally, 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.
Interventions
Orally, 2 mg, once daily
Eligibility Criteria
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (139)
Paratus Clinical Pty Ltd
Blacktown, New South Wales, 2148, Australia
Paratus Clinical Wyong Complex
Kanwal, New South Wales, 2259, Australia
Women's Health and Research Institute of Australia-WHRIA
Sydney, New South Wales, 2000, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, 4120, Australia
Medizinische Universität Graz
Graz, Styria, 8036, Austria
Landeskrankenhaus Bregenz
Bregenz, Vorarlberg, 6900, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
AZ Jan Palfijn Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
CHU Saint-Pierre/UMC Sint-Pieter
Bruxelles - Brussel, 1000, Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200, Belgium
CHU de Tivoli
La Louvière, 7100, Belgium
CHR de la Citadelle - Department of Gynaecology & Obstetrics
Liège, 4000, Belgium
Femicare vzw
Tienen, 3300, Belgium
MHAT Blagoevgrad AD
Blagoevgrad, 2700, Bulgaria
MHAT Dobrich
Dobrich, 9300, Bulgaria
MC Asklepii OOD
Dupnitsa, 2600, Bulgaria
Multiprofile Hospital for Active Treatment Uni Hospital OOD
Panagyurishte, 4500, Bulgaria
MHAT Avis Medika
Pleven, 5800, Bulgaria
Spec. Hospital for Active Treatment of Oncological Diseases
Sofia, 1233, Bulgaria
DCC Aleksandrovska
Sofia, 1431, Bulgaria
Medical Center Panaceya
Sofia, 1606, Bulgaria
MHAT Niamed
Stara Zagora, 6000, Bulgaria
Multiprofile Hospital for Active Treatment Sv. Anna
Varna, 9000, Bulgaria
SHOGAT Prof Dimitar Stamatov
Varna, 9000, Bulgaria
Ocean West Research Clinic Inc
Surrey, British Columbia, V3S 2N6, Canada
Strand Clinic
St. John's, Newfoundland and Labrador, A1A 4Y3, Canada
Ottawa Hospital-Riverside Campus
Ottawa, Ontario, K1H 7W9, Canada
Clinique OVO
Montreal, Quebec, H4P 2S4, Canada
Clinique Recherche en Sante des Femmes Inc.
Québec, G1S 2L6, Canada
Centre de recherche Saint-Louis
Québec, G1W 4R4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Gynekologicka ordinace - Ceske Budejovice
České Budějovice, 370 01, Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, 772 00, Czechia
MUDr. Martina Maresova Rosenbergova, gynekologie
Pilsen, 300 01, Czechia
Centrum gynekologicke rehabilitace
Písek, 39701, Czechia
Dr. Smrhova-Kovacs
Tábor, 39003, Czechia
MediGyn s.r.o.
Třeboň, 379 01, Czechia
GYNEKO spol. s r.o.
Vsetín, 755 01, Czechia
Aarhus Universitetshospital, Skejby
Aarhus N, 8200, Denmark
Nordsjælland Hospital Hillerød
Hillerød, 3400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
Odense C, 5000, Denmark
HUS / Naistenklinikka
Helsinki, 00029, Finland
VL-Medi Oy
Helsinki, 00510, Finland
Kymenlaakson keskussairaala
Kotka, 48210, Finland
Lääkäriasema Cantti Oy
Kuopio, 70110, Finland
Lääkärikeskus Gyneko
Oulu, 90100, Finland
Turun yliopistollinen keskussairaala
Turku, 20520, Finland
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, 68165, Germany
Frauenarztpraxis Dr. Wolfgang Clemens
Stolberg, North Rhine-Westphalia, 52222, Germany
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, 06406, Germany
emovis GmbH
Berlin, 10629, Germany
Principal SMO Kft.
Baja, 6500, Hungary
Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
Békéscsaba, 5600, Hungary
Tritonlife Robert Magankorhaz
Budapest, 1135, Hungary
Szent Anna szuleszeti-nogyogyaszati maganrendelo
Debrecen, 4024, Hungary
NAP - Rendelo, Private Clinic
Debrecen, 4028, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Komaromi Selye Janos Korhaz
Komárom, 2900, Hungary
SzSzBMK es EOK Josa Andras Oktatokorhaz
Nyíregyháza, 4400, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Midland Regional Hospital
Mullingar, Westmeath, Ireland
A.O.U. Policlinico G.Rodolico-San Marco
Catania, Sicily, 95123, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Sicily, 90146, Italy
A.O.U. Careggi
Florence, Tuscany, 50134, Italy
A.O.U.I. Verona
Verona, Veneto, 37126, Italy
Jsc "Vakk"
Kaunas, LT-51028, Lithuania
Klaipeda City Outpatient Clinic
Klaipėda, LT-93200, Lithuania
JSC Seimos gydytojas family medical center
Vilnius, LT-01118, Lithuania
JSC Gyvenk Silciau Medical Center Maxmeda
Vilnius, LT-03225, Lithuania
Private hospital and outpatient clinic "Kardiolita"
Vilnius, LT-05263, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661, Lithuania
Flevoziekenhuis
Almere Stad, 1315 RA, Netherlands
VUmc
Amsterdam, 1081 HV, Netherlands
Maasstad Ziekenhuis | Neurology Department
Rotterdam, 3079DZ, Netherlands
Kirkeparken Spesialistpraksis
Fredrikstad, 1605, Norway
Nesttun Spesialistpraksis AS
Nesttun, 5221, Norway
Medicus Oslo AS
Oslo, 0161, Norway
Stavanger Universitetssjukehus
Stavanger, 4011, Norway
Medicus AS
Trondheim, 7014, Norway
Tomaszewski Medical Center
Bialystok, 15-084, Poland
Prywatna Klinika Ginekologiczno-Poloznicza
Bialystok, 15-244, Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156, Poland
Vita Longa Sp. z o.o.
Katowice, 40-748, Poland
Medico Praktyka Lekarska
Krakow, 31-315, Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, 90-602, Poland
Centrum Medyczne Chodzki
Lublin, 20-093, Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, 20-400, Poland
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
Lublin, 20-632, Poland
VitroLive Sp. z o.o.
Szczecin, 70-483, Poland
NZOZ Zieniewicz Medical
Warsaw, 02-201, Poland
Centrum Badawcze Wspolczesnej Terapii
Warsaw, 02-679, Poland
Centro Clinico Academico - Braga
Braga, 4710-243, Portugal
CHUC - Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
Lisbon, 1449-005, Portugal
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 826 06, Slovakia
ULMUS, s r.o.
Hlohovec, 920 01, Slovakia
GA Lucenec s.r.o
Lučenec, 984 01, Slovakia
Galipea s.r.o.
Nitra, 949 01, Slovakia
Gyncentrum Nitra s.r.o.
Nitra, 949 01, Slovakia
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
Veľký Krtíš, 990 01, Slovakia
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggido, 10326, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 463-707, South Korea
Ajou University Hospital
Suwon, Gyeonggido, 443-721, South Korea
Inje University Haeundae Paik Hospital
Busan, 612-862, South Korea
Keimyung University Dongsan Medical Center
Daegu, 700-712, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
CHA Gangnam Medical Center
Seoul, 135-081, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Ewha Womans University Hospital
Seoul, 158-710, South Korea
Hospital Sanitas La Zarzuela
Aravaca, Madrid, 28023, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Ginemed
Seville, 41010, Spain
H Virgen del Rocio |Cardiology|AF|Stroke prevention
Seville, 41013, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario de Álava - Sede Txagorritxu
Vitoria-Gasteiz, Álava, 01009, Spain
Södersjukhuset AB
Stockholm, 118 83, Sweden
Karolinska Universitetssjukhuset i Solna
Stockholm, 171 76, Sweden
Danderyds sjukhus
Stockholm, 182 88, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, 33305, Taiwan
North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA, United Kingdom
North Middlesex University Hospital
London, N18 1QX, United Kingdom
Whittington Hospital
London, N19 5NF, United Kingdom
Chelsea & Westminster Hospital
London, SW10 9NH, United Kingdom
St Mary's Hospital (London)
London, W2 1NY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2017
First Posted
August 7, 2017
Study Start
July 31, 2017
Primary Completion
June 28, 2020
Study Completion
October 25, 2021
Last Updated
October 18, 2024
Record last verified: 2024-10
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.