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Uterine FibroidsPhase 3ASTEROID 5NCT03240523

A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 139 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
Vilaprisan (BAY1002670)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
139 sitesin 23 countries
Study dates
31 Jul 2017to 25 Oct 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

139 sites in 23 countries.

139 sites in 23 countries

South Korea13 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-862

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Dongguk University Ilsan Hospital

    Goyang-si, Gyeonggido, 10326

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Kangnam Sacred Heart Hospital

    Seoul, 07441

  • CHA Gangnam Medical Center

    Seoul, 135-081

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 137-701

  • Korea University Guro Hospital

    Seoul, 152-703

  • Ewha Womans University Hospital

    Seoul, 158-710

  • Ajou University Hospital

    Suwon, Gyeonggido, 443-721

Other trials in South Korea

Poland12 sites

  • Tomaszewski Medical Center

    Bialystok, 15-084

  • Prywatna Klinika Ginekologiczno-Poloznicza

    Bialystok, 15-244

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

  • Medico Praktyka Lekarska

    Krakow, 31-315

  • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

    Lodz, 90-602

  • Centrum Medyczne Chodzki

    Lublin, 20-093

  • Specjalistyczny Gabinet Ginekologiczno-Polozniczy

    Lublin, 20-400

  • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C

    Lublin, 20-632

  • VitroLive Sp. z o.o.

    Szczecin, 70-483

  • NZOZ Zieniewicz Medical

    Warsaw, 02-201

  • Centrum Badawcze Wspolczesnej Terapii

    Warsaw, 02-679

Other trials in Poland

Bulgaria11 sites

  • MHAT Blagoevgrad AD

    Blagoevgrad, 2700

  • MHAT Dobrich

    Dobrich, 9300

  • MC Asklepii OOD

    Dupnitsa, 2600

  • Multiprofile Hospital for Active Treatment Uni Hospital OOD

    Panagyurishte, 4500

  • MHAT Avis Medika

    Pleven, 5800

  • Spec. Hospital for Active Treatment of Oncological Diseases

    Sofia, 1233

  • DCC Aleksandrovska

    Sofia, 1431

  • Medical Center Panaceya

    Sofia, 1606

  • MHAT Niamed

    Stara Zagora, 6000

  • Multiprofile Hospital for Active Treatment Sv. Anna

    Varna, 9000

  • SHOGAT Prof Dimitar Stamatov

    Varna, 9000

Other trials in Bulgaria

Hungary9 sites

  • Principal SMO Kft.

    Baja, 6500

  • Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba

    Békéscsaba, 5600

  • Tritonlife Robert Magankorhaz

    Budapest, 1135

  • Szent Anna szuleszeti-nogyogyaszati maganrendelo

    Debrecen, 4024

  • NAP - Rendelo, Private Clinic

    Debrecen, 4028

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Komaromi Selye Janos Korhaz

    Komárom, 2900

  • SzSzBMK es EOK Josa Andras Oktatokorhaz

    Nyíregyháza, 4400

  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

    Szeged, 6725

Other trials in Hungary

Czechia8 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Gynekologicka ordinace - Ceske Budejovice

    České Budějovice, 370 01

  • G-Centrum Olomouc s.r.o. Dr. Skrivanek

    Olomouc, 772 00

  • MUDr. Martina Maresova Rosenbergova, gynekologie

    Pilsen, 300 01

  • Centrum gynekologicke rehabilitace

    Písek, 39701

  • Dr. Smrhova-Kovacs

    Tábor, 39003

  • MediGyn s.r.o.

    Třeboň, 379 01

  • GYNEKO spol. s r.o.

    Vsetín, 755 01

Other trials in Czechia

Taiwan8 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305

Other trials in Taiwan

Canada7 sites

  • Clinique OVO

    Montreal, Quebec, H4P 2S4

  • Ottawa Hospital-Riverside Campus

    Ottawa, Ontario, K1H 7W9

  • Clinique Recherche en Sante des Femmes Inc.

    Québec, G1S 2L6

  • Centre de recherche Saint-Louis

    Québec, G1W 4R4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • Strand Clinic

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Ocean West Research Clinic Inc

    Surrey, British Columbia, V3S 2N6

Other trials in Canada

Spain7 sites

  • Hospital Sanitas La Zarzuela

    Aravaca, Madrid, 28023

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Ginemed

    Seville, 41010

  • H Virgen del Rocio |Cardiology|AF|Stroke prevention

    Seville, 41013

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario de Álava - Sede Txagorritxu

    Vitoria-Gasteiz, Álava, 01009

Other trials in Spain

Belgium6 sites

  • CHU Saint-Pierre/UMC Sint-Pieter

    Bruxelles - Brussel, 1000

  • CU Saint-Luc/UZ St-Luc

    Bruxelles - Brussel, 1200

  • AZ Jan Palfijn Gent

    Ghent, Oost-Vlaanderen, 9000

  • CHU de Tivoli

    La Louvière, 7100

  • CHR de la Citadelle - Department of Gynaecology & Obstetrics

    Liège, 4000

  • Femicare vzw

    Tienen, 3300

Other trials in Belgium

Finland6 sites

  • HUS / Naistenklinikka

    Helsinki, 00029

  • VL-Medi Oy

    Helsinki, 00510

  • Kymenlaakson keskussairaala

    Kotka, 48210

  • Lääkäriasema Cantti Oy

    Kuopio, 70110

  • Lääkärikeskus Gyneko

    Oulu, 90100

  • Turun yliopistollinen keskussairaala

    Turku, 20520

Other trials in Finland

Lithuania6 sites

  • Jsc "Vakk"

    Kaunas, LT-51028

  • Klaipeda City Outpatient Clinic

    Klaipėda, LT-93200

  • JSC Seimos gydytojas family medical center

    Vilnius, LT-01118

  • JSC Gyvenk Silciau Medical Center Maxmeda

    Vilnius, LT-03225

  • Private hospital and outpatient clinic "Kardiolita"

    Vilnius, LT-05263

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Slovakia6 sites

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 826 06

  • ULMUS, s r.o.

    Hlohovec, 920 01

  • GA Lucenec s.r.o

    Lučenec, 984 01

  • Galipea s.r.o.

    Nitra, 949 01

  • Gyncentrum Nitra s.r.o.

    Nitra, 949 01

  • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia

    Veľký Krtíš, 990 01

Other trials in Slovakia

Norway5 sites

  • Kirkeparken Spesialistpraksis

    Fredrikstad, 1605

  • Nesttun Spesialistpraksis AS

    Nesttun, 5221

  • Medicus Oslo AS

    Oslo, 0161

  • Stavanger Universitetssjukehus

    Stavanger, 4011

  • Medicus AS

    Trondheim, 7014

Other trials in Norway

United Kingdom5 sites

  • North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA

  • North Middlesex University Hospital

    London, N18 1QX

  • Whittington Hospital

    London, N19 5NF

  • Chelsea & Westminster Hospital

    London, SW10 9NH

  • St Mary's Hospital (London)

    London, W2 1NY

Other trials in United Kingdom

Australia4 sites

  • Paratus Clinical Pty Ltd

    Blacktown, New South Wales, 2148

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Paratus Clinical Wyong Complex

    Kanwal, New South Wales, 2259

  • Women's Health and Research Institute of Australia-WHRIA

    Sydney, New South Wales, 2000

Other trials in Australia

Denmark4 sites

  • Aarhus Universitetshospital, Skejby

    Aarhus N, 8200

  • Nordsjælland Hospital Hillerød

    Hillerød, 3400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D

    Odense C, 5000

Other trials in Denmark

Germany4 sites

  • emovis GmbH

    Berlin, 10629

  • Praxis f. Gynäkologie und Geburtshilfe

    Bernburg, Saxony-Anhalt, 06406

  • Praxisklinik am Rosengarten

    Mannheim, Baden-Wurttemberg, 68165

  • Frauenarztpraxis Dr. Wolfgang Clemens

    Stolberg, North Rhine-Westphalia, 52222

Other trials in Germany

Italy4 sites

  • A.O.U. Policlinico G.Rodolico-San Marco

    Catania, Sicily, 95123

  • A.O.U. Careggi

    Florence, Tuscany, 50134

  • A.O. Ospedali Riuniti Villa Sofia-Cervello

    Palermo, Sicily, 90146

  • A.O.U.I. Verona

    Verona, Veneto, 37126

Other trials in Italy

Sweden4 sites

  • Södersjukhuset AB

    Stockholm, 118 83

  • Karolinska Universitetssjukhuset i Solna

    Stockholm, 171 76

  • Danderyds sjukhus

    Stockholm, 182 88

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Austria3 sites

  • Landeskrankenhaus Bregenz

    Bregenz, Vorarlberg, 6900

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Universitätsklinikum AKH Wien

    Vienna, 1090

Other trials in Austria

Netherlands3 sites

  • Flevoziekenhuis

    Almere Stad, 1315 RA

  • VUmc

    Amsterdam, 1081 HV

  • Maasstad Ziekenhuis | Neurology Department

    Rotterdam, 3079DZ

Other trials in Netherlands

Portugal3 sites

  • Centro Clinico Academico - Braga

    Braga, 4710-243

  • CHUC - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

    Lisbon, 1449-005

Other trials in Portugal

Ireland1 site

  • Midland Regional Hospital

    Mullingar, Westmeath

Other trials in Ireland

About this study

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

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.

Being tested
Vilaprisan (BAY1002670)
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vilaprisan (BAY1002670)Drug

    Orally, 2 mg, once daily

Study groups in NCT03240523
Study groupRoleWhat they receive
Group A1: Vilaprisan (3/1 regimen)ExperimentalOrally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Receives: Drug: Vilaprisan (BAY1002670)
Group A2: Vilaprisan (6/2 regimen)ExperimentalOrally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Receives: Drug: Vilaprisan (BAY1002670)
Group A3/B (3/2 regimen)ExperimentalOrally, 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.
Receives: Drug: Vilaprisan (BAY1002670)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 3 months (at the end of treatment perid 1)

Secondary outcomes (9)

  1. Total volume of menstrual blood loss

    Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.

    Measured: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2

  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.

    Measured: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2

  3. 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.

    Measured: At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months

  4. 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).

    Measured: Up to 24 months

  5. 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.

    Measured: Quarterly up to 24 months

  6. 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]

    Measured: By treatment period up to 24 months

  7. Percent change in volume of largest fibroid compared to baseline

    Measured by MRI (magnetic resonance imaging).

    Measured: At baseline, at 12 months and at 24 months

  8. Endometrial histology

    E.g., benign endometrium, presence or absence of hyperplasia or malignancy

    Measured: Up to 24 months

  9. Endometrial thickness

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2017
  2. Study start31 Jul 2017
  3. Primary completion28 Jun 2020
  4. Study completion25 Oct 2021

Why it stopped: Due to a change in the development program, the study was closed prematurely.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03240523
Sponsor's protocol ID
15789
Other IDs
2016-002855-48, 2016
Acronym
ASTEROID 5
Status last verified
Oct 2024
First submitted
21 Jul 2017
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 139 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in South Korea, Poland, Bulgaria, Hungary, Czechia and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to a change in the development program, the study was closed prematurely.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amenorrhea (yes/no) (time frame: At 3 months (at the end of treatment perid 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03240523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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