Trial Condition(s):
Uterine Fibroids
Assess safety and efficacy of vilaprisan in subjects with uterine fibroids (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 Universitätsklinikum AKH Wien Wien, Austria, 1090 | 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 National Taiwan University Hospital Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | 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 Virina sano, s.r.o. Gynekologicko porodnicka ambulancia 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 Galipea s.r.o. Nitra, Slovakia, 949 01 | 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 - Department of Gynaecology & Obstetrics 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 emovis GmbH Berlin, Germany, 10629 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Praxisklinik am Rosengarten Mannheim, Germany, 68165 | 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, 75185 | 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, Gynækologisk Obstetrisk Afd. D Odense C, Denmark, 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 H Virgen del Rocio |Cardiology|AF|Stroke prevention 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 General Universitario de Valencia Valencia, Spain, 46014 | 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 Centrum gynekologicke rehabilitace 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 Dr. Smrhova-Kovacs Tabor, Czech Republic, 39003 | 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 Tritonlife Robert 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 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 A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Policlinico G.Rodolico-San Marco Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U.I. 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 Ilsan Hospital Goyang-si, South Korea, 10326 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | 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 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 Spec. Hospital for Active Treatment of Oncological Diseases Sofia, Bulgaria, 1233 | 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 Dupnitsa, 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 HUS / Naistenklinikka Helsinki, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Turun yliopistollinen keskussairaala 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, 20-400 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | 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 S.C Lublin, Poland, 20-632 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations DCC Aleksandrovska 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 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 Nordsjælland Hospital Hillerød 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 National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | 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 Centro Hospitalar de Lisboa Ocidental | Clin Res Dept 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 Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | 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 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 Tomaszewski Medical Center Bialystok, Poland, 15-084 | 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, 70-483 | 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 Midland Regional Hospital Mullingar, Ireland | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations North Hampshire Hospital Basingstoke, United Kingdom, RG24 9NA | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Maasstad Ziekenhuis | Neurology Department Rotterdam, Netherlands, 3079DZ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario de Álava - Sede Txagorritxu Vitoria, Spain, 01009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital de Basurto Bilbao, Spain, 48013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MUDr. Martina Maresova Rosenbergova, gynekologie Plzen, Czech Republic, 300 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klaipeda City Outpatient Clinic Klaipeda, Lithuania, LT-93200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O. Ospedali Riuniti Villa Sofia-Cervello Palermo, Italy, 90146 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hvidovre Hospital Hvidovre, Denmark, 2650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medicus Oslo AS Oslo, Norway, 0161 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gyncentrum Nitra s.r.o. Nitra, Slovakia, 949 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Greenslopes Private Hospital Greenslopes, Australia, 4120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MediGyn s.r.o. Trebon, Czech Republic, 379 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kangnam Sacred Heart Hospital Seoul, South Korea, 07441 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologicka ordinace - Ceske Budejovice Ceske Budejovice, Czech Republic, 370 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St Mary's Hospital (London) London, United Kingdom, W2 1NY | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations VUmc AMSTERDAM, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GA Lucenec s.r.o Lucenec, Slovakia, 984 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations VL-Medi Oy Helsinki, Finland, 00510 | 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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