Trial Condition(s):
Uterine Fibroids
Assess safety and efficacy of vilaprisan in subjects with uterine fibroids (ASTEROID 5)
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 | Status | ||
|---|---|---|---|
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Landeskrankenhaus Bregenz Bregenz, Austria, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Bratislava 2, Slovakia, 826 06 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Virina sano, s.r.o. Gynekologicko porodnicka ambulancia Velky Krtis, Slovakia, 990 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations ULMUS, s r.o. Hlohovec, Slovakia, 920 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations GYNEMMA s.r.o. Malacky, Slovakia, 901 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Galipea s.r.o. Nitra, Slovakia, 949 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Femicare vzw Tienen, Belgium, 3300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CHR de la Citadelle - Department of Gynaecology & Obstetrics LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CHU Saint-Pierre/UMC Sint-Pieter BRUXELLES - BRUSSEL, Belgium, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations AZ Jan Palfijn Gent Gent, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 06406 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations emovis GmbH Berlin, Germany, 10629 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Praxisklinik am Rosengarten Mannheim, Germany, 68165 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Frauenarztpraxis Dr. Wolfgang Clemens Stolberg, Germany, 52222 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Södersjukhuset AB Stockholm, Sweden, 118 83 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Akademiska Sjukhuset Uppsala, Sweden, 75185 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations JSC Seimos gydytojas family medical center Vilnius, Lithuania, LT-01118 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D Odense C, Denmark, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ginemed Sevilla, Spain, 41010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centrum gynekologicke rehabilitace Pisek, Czech Republic, 39701 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc, Czech Republic, 772 00 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations GYNEKO spol. s r.o. Vsetin, Czech Republic, 755 01 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations NAP - Rendelo, Private Clinic Debrecen, Hungary, 4028 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations SzSzBMK es EOK Josa Andras Oktatokorhaz Nyiregyhaza, Hungary, 4400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tritonlife Robert Magankorhaz Budapest, Hungary, 1135 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Komaromi Selye Janos Korhaz Komarom, Hungary, 2900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6725 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba Bekescsaba, Hungary, 5600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Principal SMO Kft. Baja, Hungary, 6500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 463-707 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations A.O.U. Policlinico G.Rodolico-San Marco Catania, Italy, 95123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations A.O.U.I. Verona Verona, Italy, 37126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Szent Anna szuleszeti-nogyogyaszati maganrendelo Debrecen, Hungary, 4024 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ewha Womans University Hospital Seoul, South Korea, 158-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CHA Gangnam Medical Center Seoul, South Korea, 135-081 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Dongguk University Ilsan Hospital Goyang-si, South Korea, 10326 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ajou University Hospital Suwon, South Korea, 443-721 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Korea University Guro Hospital Seoul, South Korea, 152-703 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Private hospital and outpatient clinic "Kardiolita" Vilnius, Lithuania, LT-05263 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations JSC Gyvenk Silciau Medical Center Maxmeda Vilnius, Lithuania, LT-03225 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ottawa Hospital-Riverside Campus Ottawa, Canada, K1H 7W9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Clinique Recherche en Sante des Femmes Inc. Quebec, Canada, G1S 2L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations ALPHA Recherche Clinique Quebec, Canada, G3K 2P8 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Clinique OVO Montreal, Canada, H4P 2S4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ocean West Research Clinic Inc Surrey, Canada, V3S 2N6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centre de recherche Saint-Louis Quebec, Canada, G1W 4R4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MHAT Niamed Stara Zagora, Bulgaria, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MHAT Avis Medika Pleven, Bulgaria, 5800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medical Center Panaceya Sofia, Bulgaria, 1606 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Spec. Hospital for Active Treatment of Oncological Diseases Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Multiprofile Hospital for Active Treatment Uni Hospital OOD Panagyurishte, Bulgaria, 4500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations SHOGAT Prof Dimitar Stamatov Varna, Bulgaria, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MC Asklepii OOD Dupnitsa, Bulgaria, 2600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Lääkäriasema Cantti Oy Kuopio, Finland, 70110 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Lääkärikeskus Gyneko Oulu, Finland, 90100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kymenlaakson keskussairaala Kotka, Finland, 48210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations HUS / Naistenklinikka Helsinki, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Prywatna Klinika Ginekologiczno-Poloznicza Bialystok, Poland, 15-244 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz, Poland, 90-602 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin, Poland, 20-400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Vita Longa Sp. z o.o. Katowice, Poland, 40-748 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C Lublin, Poland, 20-632 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations DCC Aleksandrovska Sofia, Bulgaria, 1431 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MHAT Blagoevgrad AD Blagoevgrad, Bulgaria, 2700 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Multiprofile Hospital for Active Treatment Sv. Anna Varna, Bulgaria, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CHU de Tivoli LA LOUVIERE, Belgium, 7100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Flevoziekenhuis ALMERE, Netherlands, 1315 RA | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, Taiwan, China, 807 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations China Medical University Hospital Taichung, Taiwan, China, 40447 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Nesttun Spesialistpraksis AS Nesttun, Norway, 5221 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kirkeparken Spesialistpraksis Fredrikstad, Norway, 1605 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Stavanger Universitetssjukehus Stavanger, Norway, 4011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medicus AS Trondheim, Norway, 7014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Nordsjælland Hospital Hillerød Hillerød, Denmark, 3400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations JSC "VAKK" Kaunas, Lithuania, LT-51028 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Strand Clinic St. John's, Canada, A1A 4Y3 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Keimyung University Dongsan Medical Center Daegu, South Korea, 700-712 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Inje University Haeundae Paik Hospital Busan, South Korea, 612-862 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Paratus Clinical Pty Ltd Blacktown, Australia, 2148 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Paratus Clinical Wyong Complex Kanwal, Australia, 2259 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Women’s Health and Research Institute of Australia-WHRIA Sydney, Australia, 2000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Mackay Memorial Hospital Taipei, Taiwan, China, 10449 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Whittington Hospital London, United Kingdom, N19 5NF | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centro Hospitalar de Lisboa Ocidental Lisboa, Portugal, 1449-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CHUC - Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-075 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centrum Medyczne Chodzki Lublin, Poland, 20-093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations NZOZ Zieniewicz Medical Warszawa, Poland, 02-201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MHAT Dobrich Dobrich, Bulgaria, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tomaszewski Medical Center Bialystok, Poland, 15-084 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Chelsea & Westminster Hospital London, United Kingdom, SW10 9NH | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations North Middlesex University Hospital London, United Kingdom, N18 1QX | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations VitroLive Sp. z o.o. Szczecin, Poland, 70-483 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medico Praktyka Lekarska Krakow, Poland, 31-315 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centrum Badawcze Wspolczesnej Terapii Warszawa, Poland, 02-679 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Midland Regional Hospital Mullingar, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations North Hampshire Hospital Basingstoke, United Kingdom, RG24 9NA | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Maasstad Ziekenhuis ROTTERDAM, Netherlands, 3079 DZ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Universitario de Álava - Sede Txagorritxu Vitoria, Spain, 01009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital de Basurto Bilbao, Spain, 48013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MUDr. Martina Maresova Rosenbergova, gynekologie Plzen, Czech Republic, 300 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Klaipeda City Outpatient Clinic Klaipeda, Lithuania, LT-93200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations A.O. Ospedali Riuniti Villa Sofia-Cervello Palermo, Italy, 90146 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hvidovre Hospital Hvidovre, Denmark, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medicus Oslo AS Oslo, Norway, 0161 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Gyncentrum Nitra s.r.o. Nitra, Slovakia, 949 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Greenslopes Private Hospital Greenslopes, Australia, 4120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MediGyn s.r.o. Trebon, Czech Republic, 379 01 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kangnam Sacred Heart Hospital Seoul, South Korea, 07441 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Gynekologicka ordinace - Ceske Budejovice Ceske Budejovice, Czech Republic, 370 01 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations St Mary's Hospital (London) London, United Kingdom, W2 1NY | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations VUmc AMSTERDAM, Netherlands, 1081 HV | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations GA Lucenec s.r.o Lucenec, Slovakia, 984 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations VL-Medi Oy Helsinki, Finland, 00510 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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.Timeframe: At 3 months (at the end of treatment perid 1)
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
- Endometrial histologyE.g., benign endometrium, presence or absence of hyperplasia or malignancyTimeframe: Up to 24 months
- Endometrial thicknessTimeframe: Up to 24 months
Additional Information
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