Clinical trial NCT03240523: A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Official title: A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 766
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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