Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Uterine Fibroids Clinical Trial

— ASTEROID 5  

Official title:

A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03240523
• Other study ID #: 15789
• Secondary ID: 2016-002855-48
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

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

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