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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03240523
Other study ID # 15789
Secondary ID 2016-002855-48
Status Terminated
Phase Phase 3
First received
Last updated
Start date July 31, 2017
Est. completion date October 25, 2021

Study information

Verified date June 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 766
Est. completion date October 25, 2021
Est. primary completion date June 28, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vilaprisan (BAY1002670)
Orally, 2 mg, once daily

Locations

Country Name City State
Australia Paratus Clinical Pty Ltd Blacktown New South Wales
Australia Greenslopes Private Hospital Greenslopes Queensland
Australia Paratus Clinical Wyong Complex Kanwal New South Wales
Australia Women's Health and Research Institute of Australia-WHRIA Sydney New South Wales
Austria Landeskrankenhaus Bregenz Bregenz Vorarlberg
Austria Medizinische Universität Graz Graz Steiermark
Austria Universitätsklinikum AKH Wien Wien
Belgium CHU Saint-Pierre/UMC Sint-Pieter Bruxelles - Brussel
Belgium CU Saint-Luc/UZ St-Luc Bruxelles - Brussel
Belgium AZ Jan Palfijn Gent Gent Oost-Vlaanderen
Belgium CHU de Tivoli La Louviere
Belgium CHR de la Citadelle - Department of Gynaecology & Obstetrics Liege
Belgium Femicare vzw Tienen
Bulgaria MHAT Blagoevgrad AD Blagoevgrad
Bulgaria MHAT Dobrich Dobrich
Bulgaria MC Asklepii OOD Dupnitsa
Bulgaria Multiprofile Hospital for Active Treatment Uni Hospital OOD Panagyurishte
Bulgaria MHAT Avis Medika Pleven
Bulgaria DCC Aleksandrovska Sofia
Bulgaria Medical Center Panaceya Sofia
Bulgaria Spec. Hospital for Active Treatment of Oncological Diseases Sofia
Bulgaria MHAT Niamed Stara Zagora
Bulgaria Multiprofile Hospital for Active Treatment Sv. Anna Varna
Bulgaria SHOGAT Prof Dimitar Stamatov Varna
Canada Clinique OVO Montreal Quebec
Canada Ottawa Hospital-Riverside Campus Ottawa Ontario
Canada ALPHA Recherche Clinique Quebec
Canada Centre de recherche Saint-Louis Quebec
Canada Clinique Recherche en Sante des Femmes Inc. Quebec
Canada Strand Clinic St. John's Newfoundland and Labrador
Canada Ocean West Research Clinic Inc Surrey British Columbia
Czechia Fakultni nemocnice Brno Brno
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 Dr. Smrhova-Kovacs Tabor
Czechia MediGyn s.r.o. Trebon
Czechia GYNEKO spol. s r.o. Vsetin
Denmark Aarhus Universitetshospital, Skejby Aarhus N
Denmark Nordsjælland Hospital Hillerød Hillerød
Denmark Hvidovre Hospital Hvidovre
Denmark Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D Odense C
Finland HUS / Naistenklinikka Helsinki
Finland VL-Medi Oy Helsinki
Finland Kymenlaakson keskussairaala Kotka
Finland Lääkäriasema Cantti Oy Kuopio
Finland Lääkärikeskus Gyneko Oulu
Finland Turun yliopistollinen keskussairaala Turku
Germany emovis GmbH Berlin
Germany Praxis f. Gynäkologie und Geburtshilfe Bernburg Sachsen-Anhalt
Germany Praxisklinik am Rosengarten Mannheim Baden-Württemberg
Germany Frauenarztpraxis Dr. Wolfgang Clemens Stolberg Nordrhein-Westfalen
Hungary Principal SMO Kft. Baja
Hungary Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba Bekescsaba
Hungary Tritonlife Robert Magankorhaz Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary NAP - Rendelo, Private Clinic Debrecen
Hungary Szent Anna szuleszeti-nogyogyaszati maganrendelo Debrecen
Hungary Komaromi Selye Janos Korhaz Komarom
Hungary SzSzBMK es EOK Josa Andras Oktatokorhaz Nyiregyhaza
Hungary SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged
Ireland Midland Regional Hospital Mullingar Westmeath
Italy A.O.U. Policlinico G.Rodolico-San Marco Catania Sicilia
Italy A.O.U. Careggi Firenze Toscana
Italy A.O. Ospedali Riuniti Villa Sofia-Cervello Palermo Sicilia
Italy A.O.U.I. Verona Verona Veneto
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Dongguk University Ilsan Hospital Goyang-si Gyeonggido
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggido
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of CHA Gangnam Medical Center Seoul
Korea, Republic of Ewha Womans University Hospital Seoul
Korea, Republic of Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon Gyeonggido
Lithuania Jsc "Vakk" Kaunas
Lithuania Klaipeda City Outpatient Clinic Klaipeda
Lithuania JSC Gyvenk Silciau Medical Center Maxmeda Vilnius
Lithuania JSC Seimos gydytojas family medical center Vilnius
Lithuania Private hospital and outpatient clinic "Kardiolita" Vilnius
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius
Netherlands Flevoziekenhuis Almere
Netherlands VUmc Amsterdam
Netherlands Maasstad Ziekenhuis | Neurology Department Rotterdam
Norway Kirkeparken Spesialistpraksis Fredrikstad
Norway Nesttun Spesialistpraksis AS Nesttun
Norway Medicus Oslo AS Oslo
Norway Stavanger Universitetssjukehus Stavanger
Norway Medicus AS Trondheim
Poland Prywatna Klinika Ginekologiczno-Poloznicza Bialystok
Poland Tomaszewski Medical Center Bialystok
Poland CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice
Poland Vita Longa Sp. z o.o. Katowice
Poland Medico Praktyka Lekarska Krakow
Poland Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz
Poland Centrum Medyczne Chodzki Lublin
Poland NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C Lublin
Poland Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin
Poland VitroLive Sp. z o.o. Szczecin
Poland Centrum Badawcze Wspolczesnej Terapii Warszawa
Poland NZOZ Zieniewicz Medical Warszawa
Portugal Centro Clinico Academico - Braga Braga
Portugal CHUC - Hospitais da Universidade de Coimbra Coimbra
Portugal Centro Hospitalar de Lisboa Ocidental | Clin Res Dept Lisboa
Slovakia Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Bratislava 2
Slovakia ULMUS, s r.o. Hlohovec
Slovakia GA Lucenec s.r.o Lucenec
Slovakia Galipea s.r.o. Nitra
Slovakia Gyncentrum Nitra s.r.o. Nitra
Slovakia Virina sano, s.r.o. Gynekologicko porodnicka ambulancia Velky Krtis
Spain Hospital Sanitas La Zarzuela Aravaca Madrid
Spain Hospital de Basurto Bilbao Vizcaya
Spain Hospital Universitario 12 de Octubre Madrid
Spain Ginemed Sevilla
Spain H Virgen del Rocio |Cardiology|AF|Stroke prevention Sevilla
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Universitario de Álava - Sede Txagorritxu Vitoria Álava
Sweden Danderyds sjukhus Stockholm
Sweden Karolinska Universitetssjukhuset i Solna Stockholm
Sweden Södersjukhuset AB Stockholm
Sweden Akademiska Sjukhuset Uppsala
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Memorial Hospital at Linkou Taoyuan
United Kingdom North Hampshire Hospital Basingstoke Hampshire
United Kingdom Chelsea & Westminster Hospital London
United Kingdom North Middlesex University Hospital London
United Kingdom St Mary's Hospital (London) London
United Kingdom Whittington Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  Germany,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  Norway,  Poland,  Portugal,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
At 3 months (at the end of treatment perid 1)
Secondary Total volume of menstrual blood loss Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days. After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Secondary 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. After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Secondary 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. At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
Secondary 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). Up to 24 months
Secondary 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. Quarterly up to 24 months
Secondary 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] By treatment period up to 24 months
Secondary Percent change in volume of largest fibroid compared to baseline Measured by MRI (magnetic resonance imaging). At baseline, at 12 months and at 24 months
Secondary Endometrial histology E.g., benign endometrium, presence or absence of hyperplasia or malignancy Up to 24 months
Secondary Endometrial thickness Up to 24 months
See also
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Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A