Trial Condition(s):

Uterine Fibroids

Assess safety and efficacy of vilaprisan in subjects with uterine fibroids (ASTEROID 5)

Bayer Identifier:

15789

ClinicalTrials.gov Identifier:

NCT03240523

EudraCT Number:

2016-002855-48

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
766
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 33305

Status
Completed
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava 2, Slovakia, 826 06

Status
Completed
 
Locations

Virina sano, s.r.o. Gynekologicko porodnicka ambulancia

Velky Krtis, Slovakia, 990 01

Status
Completed
 
Locations

ULMUS, s r.o.    

Hlohovec, Slovakia, 920 01

Status
Completed
 
Locations

GYNEMMA s.r.o.

Malacky, Slovakia, 901 01

Status
Not yet recruiting
 
Locations

Galipea s.r.o.

Nitra, Slovakia, 949 01

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Femicare vzw

Tienen, Belgium, 3300

Status
Completed
 
Locations

CHR de la Citadelle - Department of Gynaecology & Obstetrics

LIEGE, Belgium, 4000

Status
Completed
 
Locations

CHU Saint-Pierre/UMC Sint-Pieter

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

AZ Jan Palfijn Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

Status
Completed
 
Locations

emovis GmbH

Berlin, Germany, 10629

Status
Completed
 
Locations

Praxisklinik am Rosengarten

Mannheim, Germany, 68165

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wolfgang Clemens

Stolberg, Germany, 52222

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Södersjukhuset AB

Stockholm, Sweden, 118 83

Status
Completed
 
Locations

Danderyds sjukhus

Stockholm, Sweden, 182 88

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 75185

Status
Completed
 
Locations

JSC Seimos gydytojas family medical center

Vilnius, Lithuania, LT-01118

Status
Completed
 
Locations

Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D

Odense C, Denmark, 5000

Status
Completed
 
Locations

Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
 
Locations

Ginemed

Sevilla, Spain, 41010

Status
Completed
 
Locations

Centrum gynekologicke rehabilitace

Pisek, Czech Republic, 39701

Status
Terminated
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Terminated
 
Locations

G-Centrum Olomouc s.r.o. Dr. Skrivanek

Olomouc, Czech Republic, 772 00

Status
Terminated
 
Locations

Dr. Smrhova-Kovacs

Tabor, Czech Republic, 39003

Status
Terminated
 
Locations

GYNEKO spol. s r.o.

Vsetin, Czech Republic, 755 01

Status
Terminated
 
Locations

NAP - Rendelo, Private Clinic

Debrecen, Hungary, 4028

Status
Completed
 
Locations

SzSzBMK es EOK Josa Andras Oktatokorhaz

Nyiregyhaza, Hungary, 4400

Status
Completed
 
Locations

Tritonlife Robert Magankorhaz

Budapest, Hungary, 1135

Status
Completed
 
Locations

Komaromi Selye Janos Korhaz

Komarom, Hungary, 2900

Status
Completed
 
Locations

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6725

Status
Completed
 
Locations

Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba

Bekescsaba, Hungary, 5600

Status
Completed
 
Locations

Principal SMO Kft.

Baja, Hungary, 6500

Status
Completed
 
Locations

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 463-707

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

A.O.U. Policlinico G.Rodolico-San Marco

Catania, Italy, 95123

Status
Completed
 
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Completed
 
Locations

Szent Anna szuleszeti-nogyogyaszati maganrendelo

Debrecen, Hungary, 4024

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 03080

Status
Completed
 
Locations

Ewha Womans University Hospital

Seoul, South Korea, 158-710

Status
Completed
 
Locations

CHA Gangnam Medical Center

Seoul, South Korea, 135-081

Status
Terminated
 
Locations

Dongguk University Ilsan Hospital

Goyang-si, South Korea, 10326

Status
Completed
 
Locations

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Completed
 
Locations

Ajou University Hospital

Suwon, South Korea, 443-721

Status
Completed
 
Locations

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea, 137-701

Status
Completed
 
Locations

Korea University Guro Hospital

Seoul, South Korea, 152-703

Status
Completed
 
Locations

Private hospital and outpatient clinic "Kardiolita"

Vilnius, Lithuania, LT-05263

Status
Completed
 
Locations

JSC Gyvenk Silciau Medical Center Maxmeda

Vilnius, Lithuania, LT-03225

Status
Completed
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Ottawa Hospital-Riverside Campus

Ottawa, Canada, K1H 7W9

Status
Completed
 
Locations

Clinique Recherche en Sante des Femmes Inc.

Quebec, Canada, G1S 2L6

Status
Completed
 
Locations

ALPHA Recherche Clinique

Quebec, Canada, G3K 2P8

Status
Completed
 
Locations

Clinique OVO

Montreal, Canada, H4P 2S4

Status
Completed
 
Locations

Ocean West Research Clinic Inc

Surrey, Canada, V3S 2N6

Status
Completed
 
Locations

Centre de recherche Saint-Louis

Quebec, Canada, G1W 4R4

Status
Completed
 
Locations

MHAT Niamed

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

MHAT Avis Medika

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Medical Center Panaceya

Sofia, Bulgaria, 1606

Status
Completed
 
Locations

Spec. Hospital for Active Treatment of Oncological Diseases

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Uni Hospital OOD

Panagyurishte, Bulgaria, 4500

Status
Completed
 
Locations

SHOGAT Prof Dimitar Stamatov

Varna, Bulgaria, 9000

Status
Completed
 
Locations

MC Asklepii OOD

Dupnitsa, Bulgaria, 2600

Status
Completed
 
Locations

Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

Status
Completed
 
Locations

Lääkärikeskus Gyneko

Oulu, Finland, 90100

Status
Completed
 
Locations

Kymenlaakson keskussairaala

Kotka, Finland, 48210

Status
Completed
 
Locations

HUS / Naistenklinikka

Helsinki, Finland, 00029

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala

Turku, Finland, 20520

Status
Completed
 
Locations

Prywatna Klinika Ginekologiczno-Poloznicza

Bialystok, Poland, 15-244

Status
Completed
 
Locations

Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

Status
Completed
 
Locations

Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, Poland, 20-400

Status
Completed
 
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

Status
Completed
 
Locations

Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

Status
Completed
 
Locations

NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

Lublin, Poland, 20-632

Status
Completed
 
Locations

DCC Aleksandrovska

Sofia, Bulgaria, 1431

Status
Completed
 
Locations

MHAT Blagoevgrad AD

Blagoevgrad, Bulgaria, 2700

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Sv. Anna

Varna, Bulgaria, 9000

Status
Completed
 
Locations

CHU de Tivoli

LA LOUVIERE, Belgium, 7100

Status
Completed
 
Locations

Flevoziekenhuis

ALMERE, Netherlands, 1315 RA

Status
Completed
 
Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, China, 807

Status
Completed
 
Locations

China Medical University Hospital

Taichung, Taiwan, China, 40447

Status
Completed
 
Locations

Nesttun Spesialistpraksis AS

Nesttun, Norway, 5221

Status
Completed
 
Locations

Kirkeparken Spesialistpraksis

Fredrikstad, Norway, 1605

Status
Completed
 
Locations

Stavanger Universitetssjukehus

Stavanger, Norway, 4011

Status
Completed
 
Locations

Medicus AS

Trondheim, Norway, 7014

Status
Completed
 
Locations

Nordsjælland Hospital Hillerød

Hillerød, Denmark, 3400

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Completed
 
Locations

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08661

Status
Completed
 
Locations

JSC "VAKK"

Kaunas, Lithuania, LT-51028

Status
Completed
 
Locations

Strand Clinic

St. John's, Canada, A1A 4Y3

Status
Completed
 
Locations

Keimyung University Dongsan Medical Center

Daegu, South Korea, 700-712

Status
Completed
 
Locations

Inje University Haeundae Paik Hospital

Busan, South Korea, 612-862

Status
Completed
 
Locations

Paratus Clinical Pty Ltd

Blacktown, Australia, 2148

Status
Completed
 
Locations

Paratus Clinical Wyong Complex

Kanwal, Australia, 2259

Status
Completed
 
Locations

Women’s Health and Research Institute of Australia-WHRIA

Sydney, Australia, 2000

Status
Completed
 
Locations

National Cheng Kung University Hospital

Tainan, Taiwan, China, 704

Status
Completed
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Mackay Memorial Hospital

Taipei, Taiwan, China, 10449

Status
Completed
 
Locations

Whittington Hospital

London, United Kingdom, N19 5NF

Status
Completed
 
Locations

Centro Hospitalar de Lisboa Ocidental

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

CHUC - Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

Centro Clinico Academico - Braga

Braga, Portugal, 4710-243

Status
Completed
 
Locations

Centrum Medyczne Chodzki

Lublin, Poland, 20-093

Status
Completed
 
Locations

NZOZ Zieniewicz Medical

Warszawa, Poland, 02-201

Status
Completed
 
Locations

MHAT Dobrich

Dobrich, Bulgaria, 9300

Status
Completed
 
Locations

Tomaszewski Medical Center

Bialystok, Poland, 15-084

Status
Completed
 
Locations

Chelsea & Westminster Hospital

London, United Kingdom, SW10 9NH

Status
Completed
 
Locations

North Middlesex University Hospital

London, United Kingdom, N18 1QX

Status
Completed
 
Locations

VitroLive Sp. z o.o.

Szczecin, Poland, 70-483

Status
Terminated
 
Locations

Medico Praktyka Lekarska

Krakow, Poland, 31-315

Status
Completed
 
Locations

Centrum Badawcze Wspolczesnej Terapii

Warszawa, Poland, 02-679

Status
Completed
 
Locations

Midland Regional Hospital

Mullingar, Ireland

Status
Completed
 
Locations

North Hampshire Hospital

Basingstoke, United Kingdom, RG24 9NA

Status
Completed
 
Locations

Maasstad Ziekenhuis

ROTTERDAM, Netherlands, 3079 DZ

Status
Completed
 
Locations

Hospital Universitario de Álava - Sede Txagorritxu

Vitoria, Spain, 01009

Status
Completed
 
Locations

Hospital de Basurto

Bilbao, Spain, 48013

Status
Completed
 
Locations

MUDr. Martina Maresova Rosenbergova, gynekologie

Plzen, Czech Republic, 300 01

Status
Completed
 
Locations

Klaipeda City Outpatient Clinic

Klaipeda, Lithuania, LT-93200

Status
Completed
 
Locations

A.O. Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy, 90146

Status
Completed
 
Locations

Hvidovre Hospital

Hvidovre, Denmark, 2650

Status
Completed
 
Locations

Medicus Oslo AS

Oslo, Norway, 0161

Status
Completed
 
Locations

Gyncentrum Nitra s.r.o.

Nitra, Slovakia, 949 01

Status
Completed
 
Locations

Greenslopes Private Hospital

Greenslopes, Australia, 4120

Status
Completed
 
Locations

MediGyn s.r.o.

Trebon, Czech Republic, 379 01

Status
Terminated
 
Locations

Kangnam Sacred Heart Hospital

Seoul, South Korea, 07441

Status
Completed
 
Locations

Gynekologicka ordinace - Ceske Budejovice

Ceske Budejovice, Czech Republic, 370 01

Status
Terminated
 
Locations

St Mary's Hospital (London)

London, United Kingdom, W2 1NY

Status
Completed
 
Locations

VUmc

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
Locations

GA Lucenec s.r.o

Lucenec, Slovakia, 984 01

Status
Completed
 
Locations

VL-Medi Oy

Helsinki, Finland, 00510

Status
Completed
 

Trial Design