A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
- Registration Number
- NCT03240523
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 766
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A2: Vilaprisan (6/2 regimen) Vilaprisan (BAY1002670) Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes Group A1: Vilaprisan (3/1 regimen) Vilaprisan (BAY1002670) Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode Group A3/B (3/2 regimen) Vilaprisan (BAY1002670) Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
- Primary Outcome Measures
Name Time Method Amenorrhea (yes/no) At 3 months (at the end of treatment perid 1) 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.
- Secondary Outcome Measures
Name Time Method Amenorrhea (yes/no) At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months Defined as menstrual blood loss (MBL) \< 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.
Percent change in volume of largest fibroid compared to baseline At baseline, at 12 months and at 24 months Measured by MRI (magnetic resonance imaging).
Total volume of menstrual blood loss After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2 Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.
Number of bleeding days After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2 From 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.
Absence of bleeding (spotting allowed) Up to 24 months 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).
Time to onset of controlled bleeding Quarterly up to 24 months Onset 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.
HMB (Heavy Menstrual Bleeding) responder rate By treatment period up to 24 months Percentage of subjects with blood loss \< 80.00 mL per 28 days and 50% reduction compared to baseline \[assessed by MP\]
Endometrial histology Up to 24 months E.g., benign endometrium, presence or absence of hyperplasia or malignancy
Endometrial thickness Up to 24 months
Trial Locations
- Locations (139)
Clinique OVO
🇨🇦Montreal, Quebec, Canada
Private hospital and outpatient clinic "Kardiolita"
🇱🇹Vilnius, Lithuania
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
JSC Gyvenk Silciau Medical Center Maxmeda
🇱🇹Vilnius, Lithuania
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
🇵🇱Lodz, Poland
VitroLive Sp. z o.o.
🇵🇱Szczecin, Poland
Centro Clinico Academico - Braga
🇵🇹Braga, Portugal
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
🇸🇰Bratislava 2, Slovakia
Chang Gung Memorial Hospital at Linkou
🇨🇳Taoyuan, Taiwan
Medical Center Panaceya
🇧🇬Sofia, Bulgaria
Jsc "Vakk"
🇱🇹Kaunas, Lithuania
Centrum Medyczne Chodzki
🇵🇱Lublin, Poland
Women's Health and Research Institute of Australia-WHRIA
🇦🇺Sydney, New South Wales, Australia
Paratus Clinical Pty Ltd
🇦🇺Blacktown, New South Wales, Australia
Greenslopes Private Hospital
🇦🇺Greenslopes, Queensland, Australia
Landeskrankenhaus Bregenz
🇦🇹Bregenz, Vorarlberg, Austria
MHAT Dobrich
🇧🇬Dobrich, Bulgaria
Multiprofile Hospital for Active Treatment Uni Hospital OOD
🇧🇬Panagyurishte, Bulgaria
Strand Clinic
🇨🇦St. John's, Newfoundland and Labrador, Canada
Universitätsklinikum AKH Wien
🇦🇹Wien, Austria
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
Lääkäriasema Cantti Oy
🇫🇮Kuopio, Finland
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang-si, Gyeonggido, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Kirkeparken Spesialistpraksis
🇳🇴Fredrikstad, Norway
Nesttun Spesialistpraksis AS
🇳🇴Nesttun, Norway
Danderyds sjukhus
🇸🇪Stockholm, Sweden
Hospital Sanitas La Zarzuela
🇪🇸Aravaca, Madrid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Ginemed
🇪🇸Sevilla, Spain
H Virgen del Rocio |Cardiology|AF|Stroke prevention
🇪🇸Sevilla, Spain
Medicus Oslo AS
🇳🇴Oslo, Norway
CLINICAL MEDICAL RESEARCH Sp. z o. o.
🇵🇱Katowice, Poland
Hospital de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Medicus AS
🇳🇴Trondheim, Norway
Tomaszewski Medical Center
🇵🇱Bialystok, Poland
Medico Praktyka Lekarska
🇵🇱Krakow, Poland
Prywatna Klinika Ginekologiczno-Poloznicza
🇵🇱Bialystok, Poland
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
🇵🇱Lublin, Poland
CHUC - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Södersjukhuset AB
🇸🇪Stockholm, Sweden
Karolinska Universitetssjukhuset i Solna
🇸🇪Stockholm, Sweden
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Hospital Universitario de Álava - Sede Txagorritxu
🇪🇸Vitoria, Álava, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Stavanger Universitetssjukehus
🇳🇴Stavanger, Norway
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
🇵🇱Lublin, Poland
GA Lucenec s.r.o
🇸🇰Lucenec, Slovakia
Gyncentrum Nitra s.r.o.
🇸🇰Nitra, Slovakia
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Chelsea & Westminster Hospital
🇬🇧London, United Kingdom
North Middlesex University Hospital
🇬🇧London, United Kingdom
St Mary's Hospital (London)
🇬🇧London, United Kingdom
Whittington Hospital
🇬🇧London, United Kingdom
Paratus Clinical Wyong Complex
🇦🇺Kanwal, New South Wales, Australia
AZ Jan Palfijn Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
CHR de la Citadelle - Department of Gynaecology & Obstetrics
🇧🇪Liege, Belgium
Femicare vzw
🇧🇪Tienen, Belgium
MC Asklepii OOD
🇧🇬Dupnitsa, Bulgaria
MHAT Avis Medika
🇧🇬Pleven, Bulgaria
Spec. Hospital for Active Treatment of Oncological Diseases
🇧🇬Sofia, Bulgaria
MHAT Blagoevgrad AD
🇧🇬Blagoevgrad, Bulgaria
DCC Aleksandrovska
🇧🇬Sofia, Bulgaria
MHAT Niamed
🇧🇬Stara Zagora, Bulgaria
Centre de recherche Saint-Louis
🇨🇦Quebec, Canada
Multiprofile Hospital for Active Treatment Sv. Anna
🇧🇬Varna, Bulgaria
SHOGAT Prof Dimitar Stamatov
🇧🇬Varna, Bulgaria
ALPHA Recherche Clinique
🇨🇦Quebec, Canada
Ocean West Research Clinic Inc
🇨🇦Surrey, British Columbia, Canada
Ottawa Hospital-Riverside Campus
🇨🇦Ottawa, Ontario, Canada
Clinique Recherche en Sante des Femmes Inc.
🇨🇦Quebec, Canada
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Dr. Smrhova-Kovacs
🇨🇿Tabor, Czechia
Gynekologicka ordinace - Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
🇨🇿Olomouc, Czechia
Centrum gynekologicke rehabilitace
🇨🇿Pisek, Czechia
MUDr. Martina Maresova Rosenbergova, gynekologie
🇨🇿Plzen, Czechia
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus N, Denmark
MediGyn s.r.o.
🇨🇿Trebon, Czechia
GYNEKO spol. s r.o.
🇨🇿Vsetin, Czechia
Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
🇩🇰Odense C, Denmark
A.O.U. Careggi
🇮🇹Firenze, Toscana, Italy
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Nordsjælland Hospital Hillerød
🇩🇰Hillerød, Denmark
Kymenlaakson keskussairaala
🇫🇮Kotka, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Praxis f. Gynäkologie und Geburtshilfe
🇩🇪Bernburg, Sachsen-Anhalt, Germany
emovis GmbH
🇩🇪Berlin, Germany
Tritonlife Robert Magankorhaz
🇭🇺Budapest, Hungary
Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
🇭🇺Bekescsaba, Hungary
Frauenarztpraxis Dr. Wolfgang Clemens
🇩🇪Stolberg, Nordrhein-Westfalen, Germany
Praxisklinik am Rosengarten
🇩🇪Mannheim, Baden-Württemberg, Germany
Principal SMO Kft.
🇭🇺Baja, Hungary
Szent Anna szuleszeti-nogyogyaszati maganrendelo
🇭🇺Debrecen, Hungary
NAP - Rendelo, Private Clinic
🇭🇺Debrecen, Hungary
Komaromi Selye Janos Korhaz
🇭🇺Komarom, Hungary
SzSzBMK es EOK Josa Andras Oktatokorhaz
🇭🇺Nyiregyhaza, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
A.O.U. Policlinico G.Rodolico-San Marco
🇮🇹Catania, Sicilia, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, Sicilia, Italy
A.O.U.I. Verona
🇮🇹Verona, Veneto, Italy
Ajou University Hospital
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
CHA Gangnam Medical Center
🇰🇷Seoul, Korea, Republic of
Klaipeda City Outpatient Clinic
🇱🇹Klaipeda, Lithuania
Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Hospital
🇰🇷Seoul, Korea, Republic of
JSC Seimos gydytojas family medical center
🇱🇹Vilnius, Lithuania
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
VUmc
🇳🇱Amsterdam, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
CHU de Tivoli
🇧🇪La Louviere, Belgium
HUS / Naistenklinikka
🇫🇮Helsinki, Finland
CHU Saint-Pierre/UMC Sint-Pieter
🇧🇪Bruxelles - Brussel, Belgium
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Lääkärikeskus Gyneko
🇫🇮Oulu, Finland
VL-Medi Oy
🇫🇮Helsinki, Finland
Midland Regional Hospital
🇮🇪Mullingar, Westmeath, Ireland
Maasstad Ziekenhuis | Neurology Department
🇳🇱Rotterdam, Netherlands
NZOZ Zieniewicz Medical
🇵🇱Warszawa, Poland
Centrum Badawcze Wspolczesnej Terapii
🇵🇱Warszawa, Poland
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
🇵🇹Lisboa, Portugal
ULMUS, s r.o.
🇸🇰Hlohovec, Slovakia
Galipea s.r.o.
🇸🇰Nitra, Slovakia
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
🇸🇰Velky Krtis, Slovakia
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
North Hampshire Hospital
🇬🇧Basingstoke, Hampshire, United Kingdom
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan