Terminated/Withdrawn

Uterine Fibroids

Bayer Identifier:

15789

ClinicalTrials.gov Identifier:

NCT03240523

EudraCT Number:

2016-002855-48

EU CT Number:

Not Available

Assess safety and efficacy of vilaprisan in subjects with uterine fibroids

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A

Trial summary

Enrollment Goal

766

Trial Dates

July 2017 - October 2021

Phase

Phase 3

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Universitätsklinikum AKH Wien	Wien, 1090, Austria
Completed	Universitätsklinikum AKH Wien	Wien, 1090, Austria
Withdrawn	Kepler Universitätsklinikum Campus IV	Linz, 4020, Austria
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Completed	Landeskrankenhaus Bregenz	Bregenz, 6900, Austria
Withdrawn	Medizinische Universität Innsbruck	Innsbruck, 6020, Austria
Completed	National Taiwan University Hospital	Taipei, 100, Taiwan
Completed	Chang Gung Memorial Hospital at Linkou	Taoyuan, 33305, Taiwan
Completed	Taichung Veterans General Hospital	Taichung, 40705, Taiwan
Completed	Univerzitna nemocnica Bratislava, Nemocnica Ruzinov	Bratislava 2, 826 06, Slovakia
Completed	Virina sano, s.r.o. Gynekologicko porodnicka ambulancia	Velky Krtis, 990 01, Slovakia
Completed	ULMUS, s r.o.	Hlohovec, 920 01, Slovakia
Withdrawn	MORAS s.r.o.	Zlate Moravce, 953 01, Slovakia
Withdrawn	GYNEMMA s.r.o.	Malacky, 901 01, Slovakia
Completed	Galipea s.r.o.	Nitra, 949 01, Slovakia
Withdrawn	UZ Antwerpen	EDEGEM, 2650, Belgium
Completed	CU Saint-Luc/UZ St-Luc	BRUXELLES - BRUSSEL, 1200, Belgium
Completed	Femicare vzw	Tienen, 3300, Belgium
Completed	CHR de la Citadelle - Department of Gynaecology & Obstetrics	LIEGE, 4000, Belgium
Completed	CHU Saint-Pierre/UMC Sint-Pieter	BRUXELLES - BRUSSEL, 1000, Belgium
Withdrawn	CHU Brugmann/UVC Brugmann	BRUXELLES - BRUSSEL, 1020, Belgium
Completed	AZ Jan Palfijn Gent	Gent, 9000, Belgium
Completed	Praxis f. Gynäkologie und Geburtshilfe	Bernburg, 06406, Germany
Withdrawn	Frauenarztpraxis Dr. Wetzel	Blankenburg, 38889, Germany
Withdrawn	Praxis Hr. Dr. A. Gerick	Aachen, 52072, Germany
Withdrawn	Charité Campus Benjamin Franklin (CBF)	Berlin, 12203, Germany
Completed	emovis GmbH	Berlin, 10629, Germany
Withdrawn	Praxis Fr. Dr. F. Greven	Hannover, 30459, Germany
Withdrawn	Vincentius-Diakonissen-Kliniken gAG	Karlsruhe, 76199, Germany
Withdrawn	Praxis Hr. Dr. K. Peters	Hamburg, 22159, Germany
Withdrawn	Heinrich-Heine-Universität Düsseldorf	Düsseldorf, 40225, Germany
Completed	Praxisklinik am Rosengarten	Mannheim, 68165, Germany
Withdrawn	Praxis Hr. Dr. T. Gent	Hamburg, 22351, Germany
Withdrawn	Praxis Hr. Dr. U. Kopprasch	Dresden, 01169, Germany
Withdrawn	Pius-Hospital Oldenburg	Oldenburg, 26121, Germany
Completed	Frauenarztpraxis Dr. Wolfgang Clemens	Stolberg, 52222, Germany
Completed	Karolinska Universitetssjukhuset i Solna	Stockholm, 171 76, Sweden
Completed	Södersjukhuset AB	Stockholm, 118 83, Sweden
Completed	Danderyds sjukhus	Stockholm, 182 88, Sweden
Completed	Akademiska Sjukhuset	Uppsala, 75185, Sweden
Completed	JSC Seimos gydytojas family medical center	Vilnius, LT-01118, Lithuania
Completed	Aarhus Universitetshospital, Skejby	Aarhus N, 8200, Denmark
Completed	Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D	Odense C, 5000, Denmark
Completed	Hospital Sanitas La Zarzuela	Aravaca, 28023, Spain
Completed	H Virgen del Rocio \|Cardiology\|AF\|Stroke prevention	Sevilla, 41013, Spain
Completed	Hospital Universitario 12 de Octubre	Madrid, 28041, Spain
Withdrawn	Hospital Regional de Malaga \| Obstetricia y Ginecologia	Malaga, 29010, Spain
Withdrawn	Hospital de la Santa Creu i Sant Pau \| Gynecology Department	Barcelona, 08025, Spain
Completed	Hospital General Universitario de Valencia	Valencia, 46014, Spain
Withdrawn	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Ginemed	Sevilla, 41010, Spain
Withdrawn	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona, 08035, Spain
Withdrawn	Hospital Clínico Universitario de Valencia	Valencia, 46010, Spain
Withdrawn	Hospital General de Villalba	Collado Villalba, 28400, Spain
Terminated	Centrum gynekologicke rehabilitace	Pisek, 39701, Czechia
Terminated	Fakultni nemocnice Brno	Brno, 625 00, Czechia
Terminated	G-Centrum Olomouc s.r.o. Dr. Skrivanek	Olomouc, 772 00, Czechia
Withdrawn	Fakultni Nemocnice Olomouc	Olomouc, 77900, Czechia
Terminated	Dr. Smrhova-Kovacs	Tabor, 39003, Czechia
Withdrawn	GYN-F s.r.o.	Hradec Kralove, 500 03, Czechia
Terminated	GYNEKO spol. s r.o.	Vsetin, 755 01, Czechia
Completed	NAP - Rendelo, Private Clinic	Debrecen, 4028, Hungary
Completed	SzSzBMK es EOK Josa Andras Oktatokorhaz	Nyiregyhaza, 4400, Hungary
Completed	Tritonlife Robert Magankorhaz	Budapest, 1135, Hungary
Completed	Komaromi Selye Janos Korhaz	Komarom, 2900, Hungary
Withdrawn	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar, 8000, Hungary
Completed	SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont	Szeged, 6725, Hungary
Completed	Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba	Bekescsaba, 5600, Hungary
Completed	Principal SMO Kft.	Baja, 6500, Hungary
Completed	Seoul National University Bundang Hospital	Seongnam-si, 463-707, Korea, Republic Of
Withdrawn	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma, 00168, Italy
Withdrawn	A.O.U. di Bologna Policlinico S.Orsola Malpighi	Bologna, 40138, Italy
Withdrawn	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano, 20122, Italy
Withdrawn	ASST Fatebenefratelli Sacco	Milano, 20122, Italy
Withdrawn	A.O.U. di Cagliari	Cagliari, 09042, Italy
Completed	A.O.U. Careggi	Firenze, 50134, Italy
Completed	A.O.U. Policlinico G.Rodolico-San Marco	Catania, 95123, Italy
Withdrawn	A.O.U. Consorziale Policlinico	Bari, 70124, Italy
Withdrawn	A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute	Udine, 33100, Italy
Completed	A.O.U.I. Verona	Verona, 37126, Italy
Completed	Szent Anna szuleszeti-nogyogyaszati maganrendelo	Debrecen, 4024, Hungary
Completed	Seoul National University Hospital	Seoul, 03080, Korea, Republic Of
Completed	Ewha Womans University Hospital	Seoul, 158-710, Korea, Republic Of
Withdrawn	Gangnam Severance Hospital, Yonsei University Health System	Seoul, 06273, Korea, Republic Of
Terminated	CHA Gangnam Medical Center	Seoul, 135-081, Korea, Republic Of
Completed	Dongguk University Ilsan Hospital	Goyang-si, 10326, Korea, Republic Of
Completed	Severance Hospital, Yonsei University Health System	Seoul, 03722, Korea, Republic Of
Withdrawn	HanYang University Medical Center	Seoul, 122-791, Korea, Republic Of
Withdrawn	BUNDANG CHA HOSPITAL	Seongnam-si, 13496, Korea, Republic Of
Completed	Ajou University Hospital	Suwon, 443-721, Korea, Republic Of
Completed	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul, 137-701, Korea, Republic Of
Completed	Korea University Guro Hospital	Seoul, 152-703, Korea, Republic Of
Completed	Private hospital and outpatient clinic "Kardiolita"	Vilnius, LT-05263, Lithuania
Completed	JSC Gyvenk Silciau Medical Center Maxmeda	Vilnius, LT-03225, Lithuania
Completed	Debreceni Egyetem Klinikai Kozpont	Debrecen, 4032, Hungary
Completed	Ottawa Hospital-Riverside Campus	Ottawa, K1H 7W9, Canada
Withdrawn	Victoria General Hospital	Winnipeg, R3T 2E8, Canada
Completed	Clinique Recherche en Sante des Femmes Inc.	Quebec, G1S 2L6, Canada
Completed	ALPHA Recherche Clinique	Quebec, G3K 2P8, Canada
Completed	Clinique OVO	Montreal, H4P 2S4, Canada
Completed	Ocean West Research Clinic Inc	Surrey, V3S 2N6, Canada
Completed	Centre de recherche Saint-Louis	Quebec, G1W 4R4, Canada
Withdrawn	Nemocnice Uherske Hradiste	Uherske Hradiste, 686 68, Czechia
Completed	MHAT Niamed	Stara Zagora, 6000, Bulgaria
Completed	MHAT Avis Medika	Pleven, 5800, Bulgaria
Completed	Medical Center Panaceya	Sofia, 1606, Bulgaria
Completed	Spec. Hospital for Active Treatment of Oncological Diseases	Sofia, 1233, Bulgaria
Completed	Multiprofile Hospital for Active Treatment Uni Hospital OOD	Panagyurishte, 4500, Bulgaria
Completed	SHOGAT Prof Dimitar Stamatov	Varna, 9000, Bulgaria
Completed	MC Asklepii OOD	Dupnitsa, 2600, Bulgaria
Completed	Lääkäriasema Cantti Oy	Kuopio, 70110, Finland
Completed	Lääkärikeskus Gyneko	Oulu, 90100, Finland
Completed	Kymenlaakson keskussairaala	Kotka, 48210, Finland
Withdrawn	Keski-Suomen sairaala Nova	Jyväskylä, 40620, Finland
Completed	HUS / Naistenklinikka	Helsinki, 00029, Finland
Completed	Turun yliopistollinen keskussairaala	Turku, 20520, Finland
Completed	Prywatna Klinika Ginekologiczno-Poloznicza	Bialystok, 15-244, Poland
Completed	Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.	Lodz, 90-602, Poland
Completed	Specjalistyczny Gabinet Ginekologiczno-Polozniczy	Lublin, 20-400, Poland
Completed	CLINICAL MEDICAL RESEARCH Sp. z o. o.	Katowice, 40-156, Poland
Completed	Vita Longa Sp. z o.o.	Katowice, 40-748, Poland
Completed	NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C	Lublin, 20-632, Poland
Completed	DCC Aleksandrovska	Sofia, 1431, Bulgaria
Completed	MHAT Blagoevgrad AD	Blagoevgrad, 2700, Bulgaria
Completed	Multiprofile Hospital for Active Treatment Sv. Anna	Varna, 9000, Bulgaria
Completed	CHU de Tivoli	LA LOUVIERE, 7100, Belgium
Withdrawn	St. Antonius Ziekenhuis	Nieuwegein, 3435 CM, Netherlands
Completed	Flevoziekenhuis	ALMERE, 1315 RA, Netherlands
Withdrawn	Gynekologicka ambulance - Opava	OPAVA 5, 747 05, Czechia
Completed	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung, 807, Taiwan
Completed	China Medical University Hospital	Taichung, 40447, Taiwan
Completed	Nesttun Spesialistpraksis AS	Nesttun, 5221, Norway
Completed	Kirkeparken Spesialistpraksis	Fredrikstad, 1605, Norway
Completed	Stavanger Universitetssjukehus	Stavanger, 4011, Norway
Completed	Medicus AS	Trondheim, 7014, Norway
Completed	Nordsjælland Hospital Hillerød	Hillerød, 3400, Denmark
Completed	Asan Medical Center	Seoul, 05505, Korea, Republic Of
Completed	Vilnius University Hospital Santaros Klinikos	Vilnius, LT-08661, Lithuania
Completed	JSC "VAKK"	Kaunas, LT-51028, Lithuania
Completed	Strand Clinic	St. John's, A1A 4Y3, Canada
Withdrawn	Women’s Health Centre	Calgary, T3M 1M4, Canada
Withdrawn	Mount Sinai Hospital	Toronto, M5G 1Z5, Canada
Completed	Keimyung University Dongsan Medical Center	Daegu, 700-712, Korea, Republic Of
Completed	Inje University Haeundae Paik Hospital	Busan, 612-862, Korea, Republic Of
Withdrawn	Hôpital Bicêtre	LE KREMLIN BICETRE Cedex, 94275, France
Withdrawn	Hôpital Pellegrin - Bordeaux	BORDEAUX, 33000, France
Withdrawn	Centre Hospitalier Universitaire - Angers	Angers, 49100, France
Withdrawn	Hopital Conception	Marseille, 13005, France
Withdrawn	Centre Hospitalier Universitaire de Reims	REIMS Cedex, 51092, France
Completed	Paratus Clinical Pty Ltd	Blacktown, 2148, Australia
Completed	Paratus Clinical Wyong Complex	Kanwal, 2259, Australia
Completed	Women’s Health and Research Institute of Australia-WHRIA	Sydney, 2000, Australia
Withdrawn	Instr. of Pediatrics, Obstetrics & Gynecology	Kiev, 04050, Ukraine
Withdrawn	Ivano-Frankivsk Regional Perinatal Center	Ivano-Frankivsk, 76018, Ukraine
Withdrawn	Lviv Regional Center of Reproductive Health	Lviv, 79008, Ukraine
Withdrawn	Univ. Clinic Multiprofile Medical Center of the ONMU	Odesa, 65082, Ukraine
Completed	National Cheng Kung University Hospital	Tainan, 704, Taiwan
Completed	Taipei Veterans General Hospital	Taipei, 11217, Taiwan
Completed	Mackay Memorial Hospital	Taipei, 10449, Taiwan
Completed	Whittington Hospital	London, N19 5NF, United Kingdom
Completed	Centro Hospitalar de Lisboa Ocidental \| Clin Res Dept	Lisboa, 1449-005, Portugal
Completed	CHUC - Hospitais da Universidade de Coimbra	Coimbra, 3000-075, Portugal
Completed	Centro Clinico Academico - Braga	Braga, 4710-243, Portugal
Withdrawn	ULSM - Hospital Pedro Hispano	Matosinhos, 4464-513, Portugal
Withdrawn	Hospital Prof. Dr. Fernando Fonseca	Amadora, 2720-276, Portugal
Completed	Centrum Medyczne Chodzki	Lublin, 20-093, Poland
Withdrawn	Gyncentrum Sp. z o.o.	Katowice, 40-851, Poland
Withdrawn	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin, 71-434, Poland
Completed	NZOZ Zieniewicz Medical	Warszawa, 02-201, Poland
Completed	MHAT Dobrich	Dobrich, 9300, Bulgaria
Withdrawn	Kyiv City Clinical Hospital 9	Kyiv, 04112, Ukraine
Completed	Tomaszewski Medical Center	Bialystok, 15-084, Poland
Withdrawn	Kiev City Clinical Endocrinology Center	Kiev, 79044, Ukraine
Withdrawn	Medical Center Motor Sich	Zaporizhzhya, 69068, Ukraine
Withdrawn	Ysbyty Gwynedd Hospital	Bangor, LL57 2PW, United Kingdom
Completed	Chelsea & Westminster Hospital	London, SW10 9NH, United Kingdom
Completed	North Middlesex University Hospital	London, N18 1QX, United Kingdom
Withdrawn	Hôpital Saint Joseph	PARIS, 75014, France
Withdrawn	Hôpital Jeanne de Flandres - Lille	LILLE, 59037, France
Terminated	VitroLive Sp. z o.o.	Szczecin, 70-483, Poland
Completed	Medico Praktyka Lekarska	Krakow, 31-315, Poland
Completed	Centrum Badawcze Wspolczesnej Terapii	Warszawa, 02-679, Poland
Withdrawn	Hospital del Mar	Barcelona, 08003, Spain
Withdrawn	Hospital QuirónSalud Toledo	Toledo, 45001, Spain
Withdrawn	Hospital Garcia de Orta \| Research Department	Almada, 2801-951, Portugal
Completed	Midland Regional Hospital	Mullingar, Ireland
Withdrawn	University College Hospital Galway	Galway, Ireland
Completed	North Hampshire Hospital	Basingstoke, RG24 9NA, United Kingdom
Withdrawn	Isala	ZWOLLE, 8025 AB, Netherlands
Completed	Maasstad Ziekenhuis \| Neurology Department	Rotterdam, 3079DZ, Netherlands
Withdrawn	Healthcare Institution Maternity Hospital no 3	Zaporizhzhya, 69071, Ukraine
Withdrawn	Royal Womens Hospital	Parkville, 3052, Australia
Completed	Hospital Universitario de Álava - Sede Txagorritxu	Vitoria, 01009, Spain
Completed	Hospital de Basurto	Bilbao, 48013, Spain
Withdrawn	Praxis Hr. E. Goeckeler-Leopold	Geseke, 59590, Germany
Completed	MUDr. Martina Maresova Rosenbergova, gynekologie	Plzen, 300 01, Czechia
Completed	Klaipeda City Outpatient Clinic	Klaipeda, LT-93200, Lithuania
Completed	A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo, 90146, Italy
Withdrawn	ASL2 Lanciano-Vasto-Chieti	Chieti, 66026, Italy
Withdrawn	KABEG Landeskrankenhaus Villach	Villach, 9500, Austria
Completed	Hvidovre Hospital	Hvidovre, 2650, Denmark
Completed	Medicus Oslo AS	Oslo, 0161, Norway
Completed	Gyncentrum Nitra s.r.o.	Nitra, 949 01, Slovakia
Completed	Greenslopes Private Hospital	Greenslopes, 4120, Australia
Withdrawn	Centro Hospitalar Universitario do Porto	Porto, 4050-651, Portugal
Terminated	MediGyn s.r.o.	Trebon, 379 01, Czechia
Withdrawn	MICS Centrum Medyczne Bydgoszcz	Bydgoszcz, 85-065, Poland
Completed	Kangnam Sacred Heart Hospital	Seoul, 07441, Korea, Republic Of
Terminated	Gynekologicka ordinace - Ceske Budejovice	Ceske Budejovice, 370 01, Czechia
Completed	St Mary's Hospital (London)	London, W2 1NY, United Kingdom
Completed	VUmc	AMSTERDAM, 1081 HV, Netherlands
Withdrawn	Maxima Medisch Centrum, locatie Veldhoven	VELDHOVEN, 5504 DB, Netherlands
Withdrawn	GYNERA	Praha 5, 156 00, Czechia
Completed	GA Lucenec s.r.o	Lucenec, 984 01, Slovakia
Withdrawn	Clinic ARS, Gynaecological department	Riga, LV-1050, Latvia
Withdrawn	Latvian Marine Medicine Center	Riga, LV-1005, Latvia
Withdrawn	1st Riga Clinical Hospital	Riga, LV-1001, Latvia
Withdrawn	I.Vasaraudzes Private Practice	Riga, LV-1011, Latvia
Withdrawn	Ingrida Briska Clinic	Sigulda, LV-2150, Latvia
Withdrawn	I.Dinsbergas Physician Practice	Riga, LV-1013, Latvia
Withdrawn	Riga East Clinical University Hospital "Gailezers"	Riga, LV-1038, Latvia
Completed	VL-Medi Oy	Helsinki, 00510, Finland
Withdrawn	Kerry University Hospital	Tralee, Ireland
Withdrawn	Femplus	Blanchardstown, Ireland

Primary Outcome

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.
Time Frame:
At 3 months (at the end of treatment perid 1)

Secondary Outcome

Total volume of menstrual blood loss
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
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.
Time Frame:
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
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.
Time Frame:
At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
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 Frame:
Up to 24 months
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.
Time Frame:
Quarterly up to 24 months
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]
Time Frame:
By treatment period up to 24 months
Percent change in volume of largest fibroid compared to baseline
Measured by MRI (magnetic resonance imaging).
Time Frame:
At baseline, at 12 months and at 24 months
Endometrial histology
E.g., benign endometrium, presence or absence of hyperplasia or malignancy
Time Frame:
Up to 24 months
Endometrial thickness
Time Frame:
Up to 24 months

Trial design

A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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