A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
NCT ID: NCT03240523
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
766 participants
INTERVENTIONAL
2017-07-31
2021-10-25
Brief Summary
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The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A1: Vilaprisan (3/1 regimen)
Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Group A2: Vilaprisan (6/2 regimen)
Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
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.
Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Interventions
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Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Paratus Clinical Pty Ltd
Blacktown, New South Wales, Australia
Paratus Clinical Wyong Complex
Kanwal, New South Wales, Australia
Women's Health and Research Institute of Australia-WHRIA
Sydney, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Landeskrankenhaus Bregenz
Bregenz, Vorarlberg, Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
AZ Jan Palfijn Gent
Ghent, Oost-Vlaanderen, Belgium
CHU Saint-Pierre/UMC Sint-Pieter
Bruxelles - Brussel, , Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, , Belgium
CHU de Tivoli
La Louvière, , Belgium
CHR de la Citadelle - Department of Gynaecology & Obstetrics
Liège, , Belgium
Femicare vzw
Tienen, , Belgium
MHAT Blagoevgrad AD
Blagoevgrad, , Bulgaria
MHAT Dobrich
Dobrich, , Bulgaria
MC Asklepii OOD
Dupnitsa, , Bulgaria
Multiprofile Hospital for Active Treatment Uni Hospital OOD
Panagyurishte, , Bulgaria
MHAT Avis Medika
Pleven, , Bulgaria
Spec. Hospital for Active Treatment of Oncological Diseases
Sofia, , Bulgaria
DCC Aleksandrovska
Sofia, , Bulgaria
Medical Center Panaceya
Sofia, , Bulgaria
MHAT Niamed
Stara Zagora, , Bulgaria
Multiprofile Hospital for Active Treatment Sv. Anna
Varna, , Bulgaria
SHOGAT Prof Dimitar Stamatov
Varna, , Bulgaria
Ocean West Research Clinic Inc
Surrey, British Columbia, Canada
Strand Clinic
St. John's, Newfoundland and Labrador, Canada
Ottawa Hospital-Riverside Campus
Ottawa, Ontario, Canada
Clinique OVO
Montreal, Quebec, Canada
Clinique Recherche en Sante des Femmes Inc.
Québec, , Canada
Centre de recherche Saint-Louis
Québec, , Canada
ALPHA Recherche Clinique
Québec, , Canada
Fakultni nemocnice Brno
Brno, , Czechia
Gynekologicka ordinace - Ceske Budejovice
České Budějovice, , Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, , Czechia
MUDr. Martina Maresova Rosenbergova, gynekologie
Pilsen, , Czechia
Centrum gynekologicke rehabilitace
Písek, , Czechia
Dr. Smrhova-Kovacs
Tábor, , Czechia
MediGyn s.r.o.
Třeboň, , Czechia
GYNEKO spol. s r.o.
Vsetín, , Czechia
Aarhus Universitetshospital, Skejby
Aarhus N, , Denmark
Nordsjælland Hospital Hillerød
Hillerød, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
Odense C, , Denmark
HUS / Naistenklinikka
Helsinki, , Finland
VL-Medi Oy
Helsinki, , Finland
Kymenlaakson keskussairaala
Kotka, , Finland
Lääkäriasema Cantti Oy
Kuopio, , Finland
Lääkärikeskus Gyneko
Oulu, , Finland
Turun yliopistollinen keskussairaala
Turku, , Finland
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, Germany
Frauenarztpraxis Dr. Wolfgang Clemens
Stolberg, North Rhine-Westphalia, Germany
Praxis f. Gynäkologie und Geburtshilfe
Bernburg, Saxony-Anhalt, Germany
emovis GmbH
Berlin, , Germany
Principal SMO Kft.
Baja, , Hungary
Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
Békéscsaba, , Hungary
Tritonlife Robert Magankorhaz
Budapest, , Hungary
Szent Anna szuleszeti-nogyogyaszati maganrendelo
Debrecen, , Hungary
NAP - Rendelo, Private Clinic
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Komaromi Selye Janos Korhaz
Komárom, , Hungary
SzSzBMK es EOK Josa Andras Oktatokorhaz
Nyíregyháza, , Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, , Hungary
Midland Regional Hospital
Mullingar, Westmeath, Ireland
A.O.U. Policlinico G.Rodolico-San Marco
Catania, Sicily, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Sicily, Italy
A.O.U. Careggi
Florence, Tuscany, Italy
A.O.U.I. Verona
Verona, Veneto, Italy
Jsc "Vakk"
Kaunas, , Lithuania
Klaipeda City Outpatient Clinic
Klaipėda, , Lithuania
JSC Seimos gydytojas family medical center
Vilnius, , Lithuania
JSC Gyvenk Silciau Medical Center Maxmeda
Vilnius, , Lithuania
Private hospital and outpatient clinic "Kardiolita"
Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Flevoziekenhuis
Almere Stad, , Netherlands
VUmc
Amsterdam, , Netherlands
Maasstad Ziekenhuis | Neurology Department
Rotterdam, , Netherlands
Kirkeparken Spesialistpraksis
Fredrikstad, , Norway
Nesttun Spesialistpraksis AS
Nesttun, , Norway
Medicus Oslo AS
Oslo, , Norway
Stavanger Universitetssjukehus
Stavanger, , Norway
Medicus AS
Trondheim, , Norway
Tomaszewski Medical Center
Bialystok, , Poland
Prywatna Klinika Ginekologiczno-Poloznicza
Bialystok, , Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, , Poland
Vita Longa Sp. z o.o.
Katowice, , Poland
Medico Praktyka Lekarska
Krakow, , Poland
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
Lodz, , Poland
Centrum Medyczne Chodzki
Lublin, , Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
Lublin, , Poland
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
Lublin, , Poland
VitroLive Sp. z o.o.
Szczecin, , Poland
NZOZ Zieniewicz Medical
Warsaw, , Poland
Centrum Badawcze Wspolczesnej Terapii
Warsaw, , Poland
Centro Clinico Academico - Braga
Braga, , Portugal
CHUC - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
Lisbon, , Portugal
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, , Slovakia
ULMUS, s r.o.
Hlohovec, , Slovakia
GA Lucenec s.r.o
Lučenec, , Slovakia
Galipea s.r.o.
Nitra, , Slovakia
Gyncentrum Nitra s.r.o.
Nitra, , Slovakia
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
Veľký Krtíš, , Slovakia
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggido, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Ajou University Hospital
Suwon, Gyeonggido, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangnam Sacred Heart Hospital
Seoul, , South Korea
CHA Gangnam Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Ewha Womans University Hospital
Seoul, , South Korea
Hospital Sanitas La Zarzuela
Aravaca, Madrid, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Ginemed
Seville, , Spain
H Virgen del Rocio |Cardiology|AF|Stroke prevention
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario de Álava - Sede Txagorritxu
Vitoria-Gasteiz, Álava, Spain
Södersjukhuset AB
Stockholm, , Sweden
Karolinska Universitetssjukhuset i Solna
Stockholm, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, , Taiwan
North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom
North Middlesex University Hospital
London, , United Kingdom
Whittington Hospital
London, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
St Mary's Hospital (London)
London, , United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
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Other Identifiers
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2016-002855-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15789
Identifier Type: -
Identifier Source: org_study_id
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