Trial Condition(s):
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids compare to ulipristal (ASTEROID 5)
Bayer Identifier:
15789
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Allgemeines Krankenhaus der Stadt Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kepler Universitätsklinikum Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Landeskrankenhaus Bregenz Bregenz, Austria, 6900 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Landeskrankenhaus - Universitätskliniken Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 333 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Bratislava 2, Slovakia, 826 06 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologicka ambulancia - MUDr. Peter Salko Velky Krtis, Slovakia, 990 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ULMUS, s r.o. Hlohovec, Slovakia, 920 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GYNEMMA s.r.o. Malacky, Slovakia, 901 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Galipea s.r.o. Nitra, Slovakia, 949 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Femicare vzw Tienen, Belgium, 3300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHR de la Citadelle LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHU Saint-Pierre/UMC Sint-Pieter BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ Jan Palfijn Gent Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 06406 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxis Hr. Dr. A. Gerick Aachen, Germany, 52072 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations emovis GmbH Berlin, Germany, 10629 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxis Fr. Dr. F. Greven Hannover, Germany, 30459 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vincentius-Diakonissen-Kliniken gAG Karlsruhe, Germany, 76199 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxis Hr. Dr. K. Peters Hamburg, Germany, 22159 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Heinrich-Heine-Universität Düsseldorf Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxisklinik am Rosengarten Mannheim, Germany, 65165 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxis Hr. Dr. T. Gent Hamburg, Germany, 22351 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxis Hr. Dr. U. Kopprasch Dresden, Germany, 01169 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Pius-Hospital Oldenburg Oldenburg, Germany, 26121 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Frauenarztpraxis Dr. Wolfgang Clemens Stolberg, Germany, 52222 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Södersjukhuset AB Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Akademiska Sjukhuset Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations JSC Seimos gydytojas family medical center Vilnius, Lithuania, LT-01118 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Odense Universitetshospital Odense C, Denmark, DK-5000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Regional de Málaga Málaga, Spain, 29011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ginemed Sevilla, Spain, 41010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General de Villalba Collado Villalba, Spain, 28400 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologicko-poradnicka ambulance Dr. Hlavackova Pisek, Czech Republic, 39701 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Nemocnice Brno Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc, Czech Republic, 772 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 775 20 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GYN-F s.r.o. Hradec Kralove, Czech Republic, 500 03 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GYNEKO spol. s r.o. Vsetin, Czech Republic, 755 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NAP - Rendelo, Private Clinic Debrecen, Hungary, 4028 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SzSzBMK es EOK Josa Andras Oktatokorhaz Nyiregyhaza, Hungary, 4400 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Robert Karoly Magankorhaz Budapest, Hungary, 1135 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Komaromi Selye Janos Korhaz Komarom, Hungary, 2900 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar, Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba Bekescsaba, Hungary, 5600 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Principal SMO Kft. Baja, Hungary, 6500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 463-707 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Univ. Alma Mater - DIMEC Dip. Scienze Mediche Chirurgiche Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Fatebenefratelli Sacco Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Cagliari Cagliari, Italy, 09042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Policlinico - Vittorio Emanuele Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Consorziale Policlinico Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.S.U. Integrata Udine Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Integrata Verona Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szent Anna szuleszeti-nogyogyaszati maganrendelo Debrecen, Hungary, 4024 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ewha Womans University Hospital Seoul, South Korea, 158-710 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHA Gangnam Medical Center Seoul, South Korea, 135-081 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dongguk University Hospital Goyang-si, South Korea, 410-773 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 150-752 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ajou University Hospital Suwon, South Korea, 443-721 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Catholic University of Korea Seoul St. Mary's Hospital Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Korea University Guro Hospital Seoul, South Korea, 152-703 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Private hospital and outpatient clinic "Kardiolita" Vilnius, Lithuania, LT-05263 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations JSC Gyvenk Silciau Medical Center Maxmeda Vilnius, Lithuania, LT-03225 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ottawa Hospital-Riverside Campus Ottawa, Canada, K1H 7W9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique Recherche en Sante des Femmes Inc. Quebec, Canada, G1S 2L6 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ALPHA Recherche Clinique Quebec, Canada, G3K 2P8 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique OVO Montreal, Canada, H4P 2S4 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ocean West Research Clinic Inc Surrey, Canada, V3S 2N6 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre de recherche Saint-Louis Quebec, Canada, G1W 4R4 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nemocnice Uherske Hradiste Uherske Hradiste, Czech Republic, 686 68 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Niamed Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Avis Medika Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center Panaceya Sofia, Bulgaria, 1606 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specialized Hosp for Act Trm of oncology disord Sofia Region Sofia, Bulgaria, 1000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Multiprofile Hospital for Active Treatment Uni Hospital OOD Panagyurishte, Bulgaria, 4500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SHOGAT Prof Dimitar Stamatov Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MC Asklepii OOD Dupnitza, Bulgaria, 2600 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lääkäriasema Cantti Oy Kuopio, Finland, 70110 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lääkärikeskus Gyneko Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kymenlaakson keskussairaala Kotka, Finland, 48210 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Keski-Suomen keskussairaala Jyväskylä, Finland, 40620 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HUS / Naistenklinikka Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Turun yliopistollinen keskussairaala, kantasairaala Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Prywatna Klinika Ginekologiczno-Poloznicza Bialystok, Poland, 15-244 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz, Poland, 90-602 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin, Poland, 20-064 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie Lublin, Poland, 20-632 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations DCC Alexandrovska EOOD Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Blagoevgrad AD Blagoevgrad, Bulgaria, 2700 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Multiprofile Hospital for Active Treatment Sv. Anna Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHU de Tivoli LA LOUVIERE, Belgium, 7100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Antonius Ziekenhuis Nieuwegein, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Flevoziekenhuis ALMERE, Netherlands, 1315 RA | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, Taiwan, China, 807 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations China Medical University Hospital Taichung, Taiwan, China, 40447 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nesttun Spesialistpraksis AS Nesttun, Norway, 5221 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kirkeparken Spesialistpraksis Fredrikstad, Norway, 1605 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Stavanger Universitetssjukehus Stavanger, Norway, 4011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medicus AS Trondheim, Norway, 7014 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hillerød Hospital Hillerød, Denmark, 3400 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations JSC "VAKK" Kaunas, Lithuania, LT-51028 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Strand Clinic St. John's, Canada, A1A 4Y3 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Keimyung University Dongsan Medical Center Daegu, South Korea, 700-712 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Inje University Haeundae Paik Hospital Busan, South Korea, 612-862 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Paratus Clinical Pty Ltd Blacktown, Australia, 2148 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Paratus Clinical Wyong Complex Kanwal, Australia, 2259 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women’s Health and Research Institute of Australia-WHRIA Sydney, Australia, 2000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Instr. of Pediatrics, Obstetrics & Gynecology Kiev, Ukraine, 04050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ivano-Frankivsk Regional Perinatal Center Ivano-Frankivsk, Ukraine, 76018 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lviv Regional Center of Reproductive Health Lviv, Ukraine, 79008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Univ. Clinic Multiprofile Medical Center of the ONMU Odesa, Ukraine, 65082 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 70428 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mackay Memorial Hospital Taipei, Taiwan, China, 10449 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Whittington Hospital London, United Kingdom, N19 5NF | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital São Francisco Xavier Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHUC - Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital de Braga Braga, Portugal, 4710-243 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unidade Local De Saude de Matosinhos, EPE – H. Pedro Hispano Senhora da Hora - Matosinhos, Portugal, 4464-513 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Prof. Dr. Fernando da Fonseca (Amadora-Sintra) Amadora, Portugal, 2720-276 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centrum Medyczne Chodzki Lublin, Poland, 20-093 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gyncentrum Clinic Sp. z o.o. Katowice, Poland, 40-851 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin, Poland, 71-270 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NZOZ Zieniewicz Medical Warszawa, Poland, 02-201 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Dobrich Dobrich, Bulgaria, 9300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyiv City Clinical Hospital 9 Kyiv, Ukraine, 04112 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tomaszewski Medical Center Bialystok, Poland, 15-084 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kiev City Clinical Endocrinology Center Kiev, Ukraine, 79044 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center Motor Sich Zaporizhzhya, Ukraine, 69068 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ysbyty Gwynedd Hospital Bangor, United Kingdom, LL57 2PW | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chelsea & Westminster Hospital London, United Kingdom, SW10 9NH | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations North Middlesex University Hospital London, United Kingdom, N18 1QX | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations VitroLive Sp. z o.o. Szczecin, Poland, 71-074 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medico Praktyka Lekarska Krakow, Poland, 31-315 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centrum Badawcze Wspolczesnej Terapii Warszawa, Poland, 02-679 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Trial Design
A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- 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. The study will be continued after the date of primary completion. Study results will be updated once the study is completed, after LPLV.Timeframe: At 3 months (at the end of treatment perid 1)
- Amenorrhea (yes/no)Timeframe: At approximately 1 year (end of treatment perid 3, including treatment breaks)
Secondary Outcome
- Total volume of menstrual blood lossAssessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.Timeframe: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
- Number of bleeding daysFrom 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.Timeframe: 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.Timeframe: 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).Timeframe: Up to 24 months
- Time to onset of controlled bleedingOnset 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.Timeframe: Quarterly up to 24 months
- HMB (Heavy Menstrual Bleeding) responder ratePercentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]Timeframe: By treatment period up to 24 months
- Percent change in volume of largest fibroid compared to baselineMeasured by MRI (magnetic resonance imaging).Timeframe: At baseline, at 12 months and at 24 months
Additional Information
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