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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 5)

Primary Purpose

Uterine Fibroids

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vilaprisan (BAY1002670)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Paratus Clinical Pty Ltd
  • Paratus Clinical Wyong Complex
  • Women's Health and Research Institute of Australia-WHRIA
  • Greenslopes Private Hospital
  • Medizinische Universität Graz
  • Landeskrankenhaus Bregenz
  • Universitätsklinikum AKH Wien
  • AZ Jan Palfijn Gent
  • CHU Saint-Pierre/UMC Sint-Pieter
  • CU Saint-Luc/UZ St-Luc
  • CHU de Tivoli
  • CHR de la Citadelle - Department of Gynaecology & Obstetrics
  • Femicare vzw
  • MHAT Blagoevgrad AD
  • MHAT Dobrich
  • MC Asklepii OOD
  • Multiprofile Hospital for Active Treatment Uni Hospital OOD
  • MHAT Avis Medika
  • Spec. Hospital for Active Treatment of Oncological Diseases
  • DCC Aleksandrovska
  • Medical Center Panaceya
  • MHAT Niamed
  • Multiprofile Hospital for Active Treatment Sv. Anna
  • SHOGAT Prof Dimitar Stamatov
  • Ocean West Research Clinic Inc
  • Strand Clinic
  • Ottawa Hospital-Riverside Campus
  • Clinique OVO
  • Clinique Recherche en Sante des Femmes Inc.
  • Centre de recherche Saint-Louis
  • ALPHA Recherche Clinique
  • Fakultni nemocnice Brno
  • Gynekologicka ordinace - Ceske Budejovice
  • G-Centrum Olomouc s.r.o. Dr. Skrivanek
  • Centrum gynekologicke rehabilitace
  • MUDr. Martina Maresova Rosenbergova, gynekologie
  • Dr. Smrhova-Kovacs
  • MediGyn s.r.o.
  • GYNEKO spol. s r.o.
  • Aarhus Universitetshospital, Skejby
  • Nordsjælland Hospital Hillerød
  • Hvidovre Hospital
  • Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
  • HUS / Naistenklinikka
  • VL-Medi Oy
  • Kymenlaakson keskussairaala
  • Lääkäriasema Cantti Oy
  • Lääkärikeskus Gyneko
  • Turun yliopistollinen keskussairaala
  • Praxisklinik am Rosengarten
  • Frauenarztpraxis Dr. Wolfgang Clemens
  • Praxis f. Gynäkologie und Geburtshilfe
  • emovis GmbH
  • Principal SMO Kft.
  • Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
  • Tritonlife Robert Magankorhaz
  • Szent Anna szuleszeti-nogyogyaszati maganrendelo
  • NAP - Rendelo, Private Clinic
  • Debreceni Egyetem Klinikai Kozpont
  • Komaromi Selye Janos Korhaz
  • SzSzBMK es EOK Josa Andras Oktatokorhaz
  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Midland Regional Hospital
  • A.O.U. Policlinico G.Rodolico-San Marco
  • A.O. Ospedali Riuniti Villa Sofia-Cervello
  • A.O.U. Careggi
  • A.O.U.I. Verona
  • Dongguk University Ilsan Hospital
  • Seoul National University Bundang Hospital
  • Ajou University Hospital
  • Inje University Haeundae Paik Hospital
  • Keimyung University Dongsan Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Kangnam Sacred Heart Hospital
  • CHA Gangnam Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Korea University Guro Hospital
  • Ewha Womans University Hospital
  • Jsc "Vakk"
  • Klaipeda City Outpatient Clinic
  • JSC Seimos gydytojas family medical center
  • JSC Gyvenk Silciau Medical Center Maxmeda
  • Private hospital and outpatient clinic "Kardiolita"
  • Vilnius University Hospital Santaros Klinikos
  • Flevoziekenhuis
  • VUmc
  • Maasstad Ziekenhuis | Neurology Department
  • Kirkeparken Spesialistpraksis
  • Nesttun Spesialistpraksis AS
  • Medicus Oslo AS
  • Stavanger Universitetssjukehus
  • Medicus AS
  • Tomaszewski Medical Center
  • Prywatna Klinika Ginekologiczno-Poloznicza
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Vita Longa Sp. z o.o.
  • Medico Praktyka Lekarska
  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
  • Centrum Medyczne Chodzki
  • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
  • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
  • VitroLive Sp. z o.o.
  • NZOZ Zieniewicz Medical
  • Centrum Badawcze Wspolczesnej Terapii
  • Centro Clinico Academico - Braga
  • CHUC - Hospitais da Universidade de Coimbra
  • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • ULMUS, s r.o.
  • GA Lucenec s.r.o
  • Galipea s.r.o.
  • Gyncentrum Nitra s.r.o.
  • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
  • Hospital Sanitas La Zarzuela
  • Hospital de Basurto
  • Hospital Universitario 12 de Octubre
  • Ginemed
  • H Virgen del Rocio |Cardiology|AF|Stroke prevention
  • Hospital General Universitario de Valencia
  • Hospital Universitario de Álava - Sede Txagorritxu
  • Södersjukhuset AB
  • Karolinska Universitetssjukhuset i Solna
  • Danderyds sjukhus
  • Akademiska Sjukhuset
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital at Linkou
  • North Hampshire Hospital
  • North Middlesex University Hospital
  • Whittington Hospital
  • Chelsea & Westminster Hospital
  • St Mary's Hospital (London)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A1: Vilaprisan (3/1 regimen)

Group A2: Vilaprisan (6/2 regimen)

Group A3/B (3/2 regimen)

Arm Description

Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode

Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total volume of menstrual blood loss
Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.
Number of bleeding days
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.
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.
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).
Time to onset of controlled bleeding
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
Percentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]
Percent change in volume of largest fibroid compared to baseline
Measured by MRI (magnetic resonance imaging).
Endometrial histology
E.g., benign endometrium, presence or absence of hyperplasia or malignancy
Endometrial thickness

Full Information

First Posted
July 21, 2017
Last Updated
June 6, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03240523
Brief Title
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Acronym
ASTEROID 5
Official Title
A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to a change in the development program, the study was closed prematurely.
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
June 28, 2020 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
Allocation
Randomized
Enrollment
766 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A1: Vilaprisan (3/1 regimen)
Arm Type
Experimental
Arm Description
Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Arm Title
Group A2: Vilaprisan (6/2 regimen)
Arm Type
Experimental
Arm Description
Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Arm Title
Group A3/B (3/2 regimen)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
Orally, 2 mg, once daily
Primary Outcome Measure Information:
Title
Amenorrhea (yes/no)
Description
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.
Time Frame
At 3 months (at the end of treatment perid 1)
Secondary Outcome Measure Information:
Title
Total volume of menstrual blood loss
Description
Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.
Time Frame
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Title
Number of bleeding days
Description
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.
Time Frame
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Title
Amenorrhea (yes/no)
Description
Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.
Time Frame
At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
Title
Absence of bleeding (spotting allowed)
Description
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 Frame
Up to 24 months
Title
Time to onset of controlled bleeding
Description
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.
Time Frame
Quarterly up to 24 months
Title
HMB (Heavy Menstrual Bleeding) responder rate
Description
Percentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]
Time Frame
By treatment period up to 24 months
Title
Percent change in volume of largest fibroid compared to baseline
Description
Measured by MRI (magnetic resonance imaging).
Time Frame
At baseline, at 12 months and at 24 months
Title
Endometrial histology
Description
E.g., benign endometrium, presence or absence of hyperplasia or malignancy
Time Frame
Up to 24 months
Title
Endometrial thickness
Time Frame
Up to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Paratus Clinical Pty Ltd
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Paratus Clinical Wyong Complex
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Women's Health and Research Institute of Australia-WHRIA
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus Bregenz
City
Bregenz
State/Province
Vorarlberg
ZIP/Postal Code
6900
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Jan Palfijn Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Saint-Pierre/UMC Sint-Pieter
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CU Saint-Luc/UZ St-Luc
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU de Tivoli
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHR de la Citadelle - Department of Gynaecology & Obstetrics
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Femicare vzw
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
MHAT Blagoevgrad AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
MHAT Dobrich
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
MC Asklepii OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Uni Hospital OOD
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Facility Name
MHAT Avis Medika
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Spec. Hospital for Active Treatment of Oncological Diseases
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
DCC Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center Panaceya
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MHAT Niamed
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sv. Anna
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
SHOGAT Prof Dimitar Stamatov
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Ocean West Research Clinic Inc
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3S 2N6
Country
Canada
Facility Name
Strand Clinic
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
Ottawa Hospital-Riverside Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
Clinique OVO
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada
Facility Name
Clinique Recherche en Sante des Femmes Inc.
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Centre de recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Gynekologicka ordinace - Ceske Budejovice
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
G-Centrum Olomouc s.r.o. Dr. Skrivanek
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Centrum gynekologicke rehabilitace
City
Pisek
ZIP/Postal Code
39701
Country
Czechia
Facility Name
MUDr. Martina Maresova Rosenbergova, gynekologie
City
Plzen
ZIP/Postal Code
300 01
Country
Czechia
Facility Name
Dr. Smrhova-Kovacs
City
Tabor
ZIP/Postal Code
39003
Country
Czechia
Facility Name
MediGyn s.r.o.
City
Trebon
ZIP/Postal Code
379 01
Country
Czechia
Facility Name
GYNEKO spol. s r.o.
City
Vsetin
ZIP/Postal Code
755 01
Country
Czechia
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Nordsjælland Hospital Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
HUS / Naistenklinikka
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
VL-Medi Oy
City
Helsinki
ZIP/Postal Code
00510
Country
Finland
Facility Name
Kymenlaakson keskussairaala
City
Kotka
ZIP/Postal Code
48210
Country
Finland
Facility Name
Lääkäriasema Cantti Oy
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Lääkärikeskus Gyneko
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Turun yliopistollinen keskussairaala
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Praxisklinik am Rosengarten
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68165
Country
Germany
Facility Name
Frauenarztpraxis Dr. Wolfgang Clemens
City
Stolberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52222
Country
Germany
Facility Name
Praxis f. Gynäkologie und Geburtshilfe
City
Bernburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06406
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Principal SMO Kft.
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Tritonlife Robert Magankorhaz
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Szent Anna szuleszeti-nogyogyaszati maganrendelo
City
Debrecen
ZIP/Postal Code
4024
Country
Hungary
Facility Name
NAP - Rendelo, Private Clinic
City
Debrecen
ZIP/Postal Code
4028
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Komaromi Selye Janos Korhaz
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
SzSzBMK es EOK Josa Andras Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Midland Regional Hospital
City
Mullingar
State/Province
Westmeath
Country
Ireland
Facility Name
A.O.U. Policlinico G.Rodolico-San Marco
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia-Cervello
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O.U.I. Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Dongguk University Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
10326
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-862
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
CHA Gangnam Medical Center
City
Seoul
ZIP/Postal Code
135-081
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Ewha Womans University Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Jsc "Vakk"
City
Kaunas
ZIP/Postal Code
LT-51028
Country
Lithuania
Facility Name
Klaipeda City Outpatient Clinic
City
Klaipeda
ZIP/Postal Code
LT-93200
Country
Lithuania
Facility Name
JSC Seimos gydytojas family medical center
City
Vilnius
ZIP/Postal Code
LT-01118
Country
Lithuania
Facility Name
JSC Gyvenk Silciau Medical Center Maxmeda
City
Vilnius
ZIP/Postal Code
LT-03225
Country
Lithuania
Facility Name
Private hospital and outpatient clinic "Kardiolita"
City
Vilnius
ZIP/Postal Code
LT-05263
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Flevoziekenhuis
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
VUmc
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Maasstad Ziekenhuis | Neurology Department
City
Rotterdam
ZIP/Postal Code
3079DZ
Country
Netherlands
Facility Name
Kirkeparken Spesialistpraksis
City
Fredrikstad
ZIP/Postal Code
1605
Country
Norway
Facility Name
Nesttun Spesialistpraksis AS
City
Nesttun
ZIP/Postal Code
5221
Country
Norway
Facility Name
Medicus Oslo AS
City
Oslo
ZIP/Postal Code
0161
Country
Norway
Facility Name
Stavanger Universitetssjukehus
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Medicus AS
City
Trondheim
ZIP/Postal Code
7014
Country
Norway
Facility Name
Tomaszewski Medical Center
City
Bialystok
ZIP/Postal Code
15-084
Country
Poland
Facility Name
Prywatna Klinika Ginekologiczno-Poloznicza
City
Bialystok
ZIP/Postal Code
15-244
Country
Poland
Facility Name
CLINICAL MEDICAL RESEARCH Sp. z o. o.
City
Katowice
ZIP/Postal Code
40-156
Country
Poland
Facility Name
Vita Longa Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Medico Praktyka Lekarska
City
Krakow
ZIP/Postal Code
31-315
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
City
Lodz
ZIP/Postal Code
90-602
Country
Poland
Facility Name
Centrum Medyczne Chodzki
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Specjalistyczny Gabinet Ginekologiczno-Polozniczy
City
Lublin
ZIP/Postal Code
20-400
Country
Poland
Facility Name
NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
City
Lublin
ZIP/Postal Code
20-632
Country
Poland
Facility Name
VitroLive Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-483
Country
Poland
Facility Name
NZOZ Zieniewicz Medical
City
Warszawa
ZIP/Postal Code
02-201
Country
Poland
Facility Name
Centrum Badawcze Wspolczesnej Terapii
City
Warszawa
ZIP/Postal Code
02-679
Country
Poland
Facility Name
Centro Clinico Academico - Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
CHUC - Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
City
Bratislava 2
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
ULMUS, s r.o.
City
Hlohovec
ZIP/Postal Code
920 01
Country
Slovakia
Facility Name
GA Lucenec s.r.o
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Galipea s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gyncentrum Nitra s.r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
City
Velky Krtis
ZIP/Postal Code
990 01
Country
Slovakia
Facility Name
Hospital Sanitas La Zarzuela
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Ginemed
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
H Virgen del Rocio |Cardiology|AF|Stroke prevention
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario de Álava - Sede Txagorritxu
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Södersjukhuset AB
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset i Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
North Hampshire Hospital
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
North Middlesex University Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
Chelsea & Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
St Mary's Hospital (London)
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
URL
http://clinicaltrials.bayer.com
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

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