Uterine Fibroids Clinical Trial
— ASTEROID 5Official title:
A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Verified date | June 2023 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bayer |
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,
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 |
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