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

EU CT Number:

Not Available

Terminated/Withdrawn

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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Universitätsklinikum AKH Wien

Wien, Austria, 1090

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Medizinische Universität Graz

Graz, Austria, 8036

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Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

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National Taiwan University Hospital

Taipei, Taiwan, China, 100

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Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 33305

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Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

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Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava 2, Slovakia, 826 06

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

Velky Krtis, Slovakia, 990 01

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ULMUS, s r.o.    

Hlohovec, Slovakia, 920 01

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Galipea s.r.o.

Nitra, Slovakia, 949 01

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CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

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Femicare vzw

Tienen, Belgium, 3300

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CHR de la Citadelle - Department of Gynaecology & Obstetrics

LIEGE, Belgium, 4000

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CHU Saint-Pierre/UMC Sint-Pieter

BRUXELLES - BRUSSEL, Belgium, 1000

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AZ Jan Palfijn Gent

Gent, Belgium, 9000

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Praxis f. Gynäkologie und Geburtshilfe

Bernburg, Germany, 06406

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emovis GmbH

Berlin, Germany, 10629

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Praxisklinik am Rosengarten

Mannheim, Germany, 68165

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Frauenarztpraxis Dr. Wolfgang Clemens

Stolberg, Germany, 52222

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Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

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Södersjukhuset AB

Stockholm, Sweden, 118 83

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Danderyds sjukhus

Stockholm, Sweden, 182 88

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Akademiska Sjukhuset

Uppsala, Sweden, 75185

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JSC Seimos gydytojas family medical center

Vilnius, Lithuania, LT-01118

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Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

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Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D

Odense C, Denmark, 5000

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Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

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H Virgen del Rocio |Cardiology|AF|Stroke prevention

Sevilla, Spain, 41013

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Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

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Hospital General Universitario de Valencia

Valencia, Spain, 46014

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Ginemed

Sevilla, Spain, 41010

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Centrum gynekologicke rehabilitace

Pisek, Czech Republic, 39701

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Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

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

Olomouc, Czech Republic, 772 00

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Dr. Smrhova-Kovacs

Tabor, Czech Republic, 39003

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GYNEKO spol. s r.o.

Vsetin, Czech Republic, 755 01

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NAP - Rendelo, Private Clinic

Debrecen, Hungary, 4028

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SzSzBMK es EOK Josa Andras Oktatokorhaz

Nyiregyhaza, Hungary, 4400

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Tritonlife Robert Magankorhaz

Budapest, Hungary, 1135

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Komaromi Selye Janos Korhaz

Komarom, Hungary, 2900

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SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6725

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Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba

Bekescsaba, Hungary, 5600

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Principal SMO Kft.

Baja, Hungary, 6500

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Seoul National University Bundang Hospital

Seongnam-si, South Korea, 463-707

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A.O.U. Careggi

Firenze, Italy, 50134

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

Catania, Italy, 95123

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A.O.U.I. Verona

Verona, Italy, 37126

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Szent Anna szuleszeti-nogyogyaszati maganrendelo

Debrecen, Hungary, 4024

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Seoul National University Hospital

Seoul, South Korea, 03080

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Ewha Womans University Hospital

Seoul, South Korea, 158-710

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CHA Gangnam Medical Center

Seoul, South Korea, 135-081

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Dongguk University Ilsan Hospital

Goyang-si, South Korea, 10326

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Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

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Ajou University Hospital

Suwon, South Korea, 443-721

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

Seoul, South Korea, 137-701

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Korea University Guro Hospital

Seoul, South Korea, 152-703

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Private hospital and outpatient clinic "Kardiolita"

Vilnius, Lithuania, LT-05263

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JSC Gyvenk Silciau Medical Center Maxmeda

Vilnius, Lithuania, LT-03225

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Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

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Ottawa Hospital-Riverside Campus

Ottawa, Canada, K1H 7W9

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Clinique Recherche en Sante des Femmes Inc.

Quebec, Canada, G1S 2L6

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ALPHA Recherche Clinique

Quebec, Canada, G3K 2P8

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Clinique OVO

Montreal, Canada, H4P 2S4

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Ocean West Research Clinic Inc

Surrey, Canada, V3S 2N6

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Centre de recherche Saint-Louis

Quebec, Canada, G1W 4R4

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MHAT Niamed

Stara Zagora, Bulgaria, 6000

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MHAT Avis Medika

Pleven, Bulgaria, 5800

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Medical Center Panaceya

Sofia, Bulgaria, 1606

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Spec. Hospital for Active Treatment of Oncological Diseases

Sofia, Bulgaria, 1233

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Multiprofile Hospital for Active Treatment Uni Hospital OOD

Panagyurishte, Bulgaria, 4500

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SHOGAT Prof Dimitar Stamatov

Varna, Bulgaria, 9000

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MC Asklepii OOD

Dupnitsa, Bulgaria, 2600

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Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

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Lääkärikeskus Gyneko

Oulu, Finland, 90100

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Kymenlaakson keskussairaala

Kotka, Finland, 48210

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HUS / Naistenklinikka

Helsinki, Finland, 00029

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Turun yliopistollinen keskussairaala

Turku, Finland, 20520

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Prywatna Klinika Ginekologiczno-Poloznicza

Bialystok, Poland, 15-244

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Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

Lodz, Poland, 90-602

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Specjalistyczny Gabinet Ginekologiczno-Polozniczy

Lublin, Poland, 20-400

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CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

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Vita Longa Sp. z o.o.

Katowice, Poland, 40-748

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NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

Lublin, Poland, 20-632

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DCC Aleksandrovska

Sofia, Bulgaria, 1431

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MHAT Blagoevgrad AD

Blagoevgrad, Bulgaria, 2700

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Multiprofile Hospital for Active Treatment Sv. Anna

Varna, Bulgaria, 9000

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CHU de Tivoli

LA LOUVIERE, Belgium, 7100

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Flevoziekenhuis

ALMERE, Netherlands, 1315 RA

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, China, 807

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China Medical University Hospital

Taichung, Taiwan, China, 40447

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Nesttun Spesialistpraksis AS

Nesttun, Norway, 5221

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Kirkeparken Spesialistpraksis

Fredrikstad, Norway, 1605

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Stavanger Universitetssjukehus

Stavanger, Norway, 4011

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Medicus AS

Trondheim, Norway, 7014

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Nordsjælland Hospital Hillerød

Hillerød, Denmark, 3400

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Asan Medical Center

Seoul, South Korea, 05505

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Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08661

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JSC "VAKK"

Kaunas, Lithuania, LT-51028

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Strand Clinic

St. John's, Canada, A1A 4Y3

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Keimyung University Dongsan Medical Center

Daegu, South Korea, 700-712

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Inje University Haeundae Paik Hospital

Busan, South Korea, 612-862

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Paratus Clinical Pty Ltd

Blacktown, Australia, 2148

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Paratus Clinical Wyong Complex

Kanwal, Australia, 2259

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Women’s Health and Research Institute of Australia-WHRIA

Sydney, Australia, 2000

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National Cheng Kung University Hospital

Tainan, Taiwan, China, 704

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Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

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Mackay Memorial Hospital

Taipei, Taiwan, China, 10449

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Whittington Hospital

London, United Kingdom, N19 5NF

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Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

Lisboa, Portugal, 1449-005

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CHUC - Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-075

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Centro Clinico Academico - Braga

Braga, Portugal, 4710-243

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Centrum Medyczne Chodzki

Lublin, Poland, 20-093

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NZOZ Zieniewicz Medical

Warszawa, Poland, 02-201

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MHAT Dobrich

Dobrich, Bulgaria, 9300

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Tomaszewski Medical Center

Bialystok, Poland, 15-084

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Chelsea & Westminster Hospital

London, United Kingdom, SW10 9NH

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North Middlesex University Hospital

London, United Kingdom, N18 1QX

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VitroLive Sp. z o.o.

Szczecin, Poland, 70-483

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Medico Praktyka Lekarska

Krakow, Poland, 31-315

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Centrum Badawcze Wspolczesnej Terapii

Warszawa, Poland, 02-679

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Midland Regional Hospital

Mullingar, Ireland

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North Hampshire Hospital

Basingstoke, United Kingdom, RG24 9NA

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Maasstad Ziekenhuis | Neurology Department

Rotterdam, Netherlands, 3079DZ

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Hospital Universitario de Álava - Sede Txagorritxu

Vitoria, Spain, 01009

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Hospital de Basurto

Bilbao, Spain, 48013

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MUDr. Martina Maresova Rosenbergova, gynekologie

Plzen, Czech Republic, 300 01

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Klaipeda City Outpatient Clinic

Klaipeda, Lithuania, LT-93200

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A.O. Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy, 90146

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Hvidovre Hospital

Hvidovre, Denmark, 2650

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Medicus Oslo AS

Oslo, Norway, 0161

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Gyncentrum Nitra s.r.o.

Nitra, Slovakia, 949 01

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Greenslopes Private Hospital

Greenslopes, Australia, 4120

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MediGyn s.r.o.

Trebon, Czech Republic, 379 01

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Kangnam Sacred Heart Hospital

Seoul, South Korea, 07441

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Gynekologicka ordinace - Ceske Budejovice

Ceske Budejovice, Czech Republic, 370 01

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St Mary's Hospital (London)

London, United Kingdom, W2 1NY

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VUmc

AMSTERDAM, Netherlands, 1081 HV

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GA Lucenec s.r.o

Lucenec, Slovakia, 984 01

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VL-Medi Oy

Helsinki, Finland, 00510

Trial Design