A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 5)

October 17, 2024 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
766

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Paratus Clinical Pty Ltd
      • Kanwal, New South Wales, Australia, 2259
        • Paratus Clinical Wyong Complex
      • Sydney, New South Wales, Australia, 2000
        • Women's Health and Research Institute of Australia-WHRIA
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
  • Austria
      • Wien, Austria, 1090
        • Universitätsklinikum AKH Wien
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universität Graz
    • Vorarlberg
      • Bregenz, Vorarlberg, Austria, 6900
        • Landeskrankenhaus Bregenz
  • Belgium
      • Bruxelles - Brussel, Belgium, 1200
        • CU Saint-Luc/UZ St-Luc
      • Bruxelles - Brussel, Belgium, 1000
        • CHU Saint-Pierre/UMC Sint-Pieter
      • La Louviere, Belgium, 7100
        • CHU de Tivoli
      • Liege, Belgium, 4000
        • CHR de la Citadelle - Department of Gynaecology & Obstetrics
      • Tienen, Belgium, 3300
        • Femicare vzw
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • AZ Jan Palfijn Gent
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • MHAT Blagoevgrad AD
      • Dobrich, Bulgaria, 9300
        • MHAT Dobrich
      • Dupnitsa, Bulgaria, 2600
        • MC Asklepii OOD
      • Panagyurishte, Bulgaria, 4500
        • Multiprofile Hospital for Active Treatment Uni Hospital OOD
      • Pleven, Bulgaria, 5800
        • MHAT Avis Medika
      • Sofia, Bulgaria, 1431
        • DCC Aleksandrovska
      • Sofia, Bulgaria, 1233
        • Spec. Hospital for Active Treatment of Oncological Diseases
      • Sofia, Bulgaria, 1606
        • Medical Center Panaceya
      • Stara Zagora, Bulgaria, 6000
        • MHAT Niamed
      • Varna, Bulgaria, 9000
        • SHOGAT Prof Dimitar Stamatov
      • Varna, Bulgaria, 9000
        • Multiprofile Hospital for Active Treatment Sv. Anna
  • Canada
      • Quebec, Canada, G3K 2P8
        • ALPHA Recherche Clinique
      • Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
      • Quebec, Canada, G1S 2L6
        • Clinique Recherche en Sante des Femmes Inc.
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 2N6
        • Ocean West Research Clinic Inc
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Strand Clinic
    • Ontario
      • Ottawa, Ontario, Canada, K1H 7W9
        • Ottawa Hospital-Riverside Campus
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique ovo
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Ceske Budejovice, Czechia, 370 01
        • Gynekologicka ordinace - Ceske Budejovice
      • Olomouc, Czechia, 772 00
        • G-Centrum Olomouc s.r.o. Dr. Skrivanek
      • Pisek, Czechia, 39701
        • Centrum gynekologicke rehabilitace
      • Plzen, Czechia, 300 01
        • MUDr. Martina Maresova Rosenbergova, gynekologie
      • Tabor, Czechia, 39003
        • Dr. Smrhova-Kovacs
      • Trebon, Czechia, 379 01
        • MediGyn s.r.o.
      • Vsetin, Czechia, 755 01
        • GYNEKO spol. s r.o.
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Skejby
      • Hillerød, Denmark, 3400
        • Nordsjælland Hospital Hillerød
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Odense C, Denmark, 5000
        • Odense Universitetshospital, Gynækologisk Obstetrisk Afd. D
  • Finland
      • Helsinki, Finland, 00029
        • HUS / Naistenklinikka
      • Helsinki, Finland, 00510
        • VL-Medi Oy
      • Kotka, Finland, 48210
        • Kymenlaakson keskussairaala
      • Kuopio, Finland, 70110
        • Lääkäriasema Cantti Oy
      • Oulu, Finland, 90100
        • Lääkärikeskus Gyneko
      • Turku, Finland, 20520
        • Turun Yliopistollinen keskussairaala
  • Germany
      • Berlin, Germany, 10629
        • emovis GmbH
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68165
        • Praxisklinik am Rosengarten
    • Nordrhein-Westfalen
      • Stolberg, Nordrhein-Westfalen, Germany, 52222
        • Frauenarztpraxis Dr. Wolfgang Clemens
    • Sachsen-Anhalt
      • Bernburg, Sachsen-Anhalt, Germany, 06406
        • Praxis f. Gynäkologie und Geburtshilfe
  • Hungary
      • Baja, Hungary, 6500
        • Principal SMO Kft.
      • Bekescsaba, Hungary, 5600
        • Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba
      • Budapest, Hungary, 1135
        • Tritonlife Robert Magankorhaz
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungary, 4028
        • NAP - Rendelo, Private Clinic
      • Debrecen, Hungary, 4024
        • Szent Anna szuleszeti-nogyogyaszati maganrendelo
      • Komarom, Hungary, 2900
        • Komaromi Selye Janos Korhaz
      • Nyiregyhaza, Hungary, 4400
        • SzSzBMK es EOK Josa Andras Oktatokorhaz
      • Szeged, Hungary, 6725
        • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Ireland
    • Westmeath
      • Mullingar, Westmeath, Ireland
        • Midland Regional Hospital
  • Italy
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • A.O.U. Policlinico G.Rodolico-San Marco
      • Palermo, Sicilia, Italy, 90146
        • A.O. Ospedali Riuniti Villa Sofia-Cervello
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • A.O.U. Careggi
    • Veneto
      • Verona, Veneto, Italy, 37126
        • A.O.U.I. Verona
  • Korea, Republic of
      • Busan, Korea, Republic of, 612-862
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135-081
        • CHA Gangnam Medical Center
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Hospital
      • Seoul, Korea, Republic of, 07441
        • KangNam Sacred Heart Hospital
    • Gyeonggido
      • Goyang-si, Gyeonggido, Korea, Republic of, 10326
        • Dongguk University Ilsan Hospital
      • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Suwon, Gyeonggido, Korea, Republic of, 443-721
        • Ajou University Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-51028
        • Jsc "Vakk"
      • Klaipeda, Lithuania, LT-93200
        • Klaipeda City Outpatient Clinic
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santaros Klinikos
      • Vilnius, Lithuania, LT-01118
        • JSC Seimos gydytojas family medical center
      • Vilnius, Lithuania, LT-03225
        • JSC Gyvenk Silciau Medical Center Maxmeda
      • Vilnius, Lithuania, LT-05263
        • Private hospital and outpatient clinic "Kardiolita"
  • Netherlands
      • Almere, Netherlands, 1315 RA
        • Flevoziekenhuis
      • Amsterdam, Netherlands, 1081 HV
        • VUmc
      • Rotterdam, Netherlands, 3079DZ
        • Maasstad Ziekenhuis | Neurology Department
  • Norway
      • Fredrikstad, Norway, 1605
        • Kirkeparken Spesialistpraksis
      • Nesttun, Norway, 5221
        • Nesttun Spesialistpraksis AS
      • Oslo, Norway, 0161
        • Medicus Oslo AS
      • Stavanger, Norway, 4011
        • Stavanger Universitetssjukehus
      • Trondheim, Norway, 7014
        • Medicus AS
  • Poland
      • Bialystok, Poland, 15-244
        • Prywatna Klinika Ginekologiczno-Poloznicza
      • Bialystok, Poland, 15-084
        • Tomaszewski Medical Center
      • Katowice, Poland, 40-156
        • CLINICAL MEDICAL RESEARCH Sp. z o. o.
      • Katowice, Poland, 40-748
        • Vita Longa Sp. z o.o.
      • Krakow, Poland, 31-315
        • Medico Praktyka Lekarska
      • Lodz, Poland, 90-602
        • Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.
      • Lublin, Poland, 20-093
        • Centrum Medyczne Chodzki
      • Lublin, Poland, 20-400
        • Specjalistyczny Gabinet Ginekologiczno-Polozniczy
      • Lublin, Poland, 20-632
        • NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C
      • Szczecin, Poland, 70-483
        • VitroLive Sp. z o.o.
      • Warszawa, Poland, 02-679
        • Centrum Badawcze Wspolczesnej Terapii
      • Warszawa, Poland, 02-201
        • Nzoz Zieniewicz Medical
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clinico Academico - Braga
      • Coimbra, Portugal, 3000-075
        • CHUC - Hospitais da Universidade de Coimbra
      • Lisboa, Portugal, 1449-005
        • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
  • Slovakia
      • Bratislava 2, Slovakia, 826 06
        • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
      • Hlohovec, Slovakia, 920 01
        • ULMUS, s r.o.
      • Lucenec, Slovakia, 984 01
        • GA Lucenec s.r.o
      • Nitra, Slovakia, 949 01
        • Galipea s.r.o.
      • Nitra, Slovakia, 949 01
        • Gyncentrum Nitra s.r.o.
      • Velky Krtis, Slovakia, 990 01
        • Virina sano, s.r.o. Gynekologicko porodnicka ambulancia
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Sevilla, Spain, 41010
        • Ginemed
      • Sevilla, Spain, 41013
        • H Virgen del Rocio |Cardiology|AF|Stroke prevention
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • Madrid
      • Aravaca, Madrid, Spain, 28023
        • Hospital Sanitas La Zarzuela
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
    • Álava
      • Vitoria, Álava, Spain, 01009
        • Hospital Universitario de Álava - Sede Txagorritxu
  • Sweden
      • Stockholm, Sweden, 182 88
        • Danderyds Sjukhus
      • Stockholm, Sweden, 118 83
        • Sodersjukhuset AB
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset i Solna
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital at Linkou
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Chelsea & Westminster Hospital
      • London, United Kingdom, N18 1QX
        • North Middlesex University Hospital
      • London, United Kingdom, N19 5NF
        • Whittington Hospital
      • London, United Kingdom, W2 1NY
        • St Mary's Hospital (London)
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • North Hampshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A1: Vilaprisan (3/1 regimen)
Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Experimental: Group A2: Vilaprisan (6/2 regimen)
Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Experimental: Group A3/B (3/2 regimen)

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amenorrhea (yes/no)
Time Frame: At 3 months (at the end of treatment perid 1)

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total volume of menstrual blood loss
Time Frame: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
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
Number of bleeding days
Time Frame: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
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
Amenorrhea (yes/no)
Time Frame: At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
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
Absence of bleeding (spotting allowed)
Time Frame: Up to 24 months
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
Time to onset of controlled bleeding
Time Frame: Quarterly up to 24 months
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
HMB (Heavy Menstrual Bleeding) responder rate
Time Frame: By treatment period up to 24 months
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
Percent change in volume of largest fibroid compared to baseline
Time Frame: At baseline, at 12 months and at 24 months
Measured by MRI (magnetic resonance imaging).
At baseline, at 12 months and at 24 months
Endometrial histology
Time Frame: Up to 24 months
E.g., benign endometrium, presence or absence of hyperplasia or malignancy
Up to 24 months
Endometrial thickness
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15789
  • 2016-002855-48 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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