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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03240523




Registration number
NCT03240523
Ethics application status
Date submitted
21/07/2017
Date registered
7/08/2017

Titles & IDs
Public title
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Scientific title
A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Secondary ID [1] 0 0
2016-002855-48
Secondary ID [2] 0 0
15789
Universal Trial Number (UTN)
Trial acronym
ASTEROID 5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroids 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vilaprisan (BAY1002670)

Experimental: Group A1: Vilaprisan (3/1 regimen) - Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode

Experimental: Group A2: Vilaprisan (6/2 regimen) - Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes

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.


Treatment: Drugs: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Amenorrhea (yes/no)
Timepoint [1] 0 0
At 3 months (at the end of treatment perid 1)
Secondary outcome [1] 0 0
Total volume of menstrual blood loss
Timepoint [1] 0 0
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Secondary outcome [2] 0 0
Number of bleeding days
Timepoint [2] 0 0
After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2
Secondary outcome [3] 0 0
Amenorrhea (yes/no)
Timepoint [3] 0 0
At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
Secondary outcome [4] 0 0
Absence of bleeding (spotting allowed)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Time to onset of controlled bleeding
Timepoint [5] 0 0
Quarterly up to 24 months
Secondary outcome [6] 0 0
HMB (Heavy Menstrual Bleeding) responder rate
Timepoint [6] 0 0
By treatment period up to 24 months
Secondary outcome [7] 0 0
Percent change in volume of largest fibroid compared to baseline
Timepoint [7] 0 0
At baseline, at 12 months and at 24 months
Secondary outcome [8] 0 0
Endometrial histology
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Endometrial thickness
Timepoint [9] 0 0
Up to 24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2021
Sample size
Target
Accrual to date
Final
766
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical Wyong Complex - Kanwal
Recruitment hospital [3] 0 0
Women's Health and Research Institute of Australia-WHRIA - Sydney
Recruitment hospital [4] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Steiermark
Country [2] 0 0
Austria
State/province [2] 0 0
Vorarlberg
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Oost-Vlaanderen
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles - Brussel
Country [6] 0 0
Belgium
State/province [6] 0 0
La Louviere
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Belgium
State/province [8] 0 0
Tienen
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Blagoevgrad
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Dobrich
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Dupnitsa
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Panagyurishte
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Pleven
Country [14] 0 0
Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Canada
State/province [17] 0 0
British Columbia
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Canada
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Newfoundland and Labrador
Country [19] 0 0
Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Ceske Budejovice
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Czechia
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Olomouc
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Czechia
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Pisek
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Czechia
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Plzen
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Czechia
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Tabor
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Czechia
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Trebon
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Vsetin
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Aarhus N
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Denmark
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Hillerød
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Denmark
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Hvidovre
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Denmark
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Odense C
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Finland
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Helsinki
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Finland
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Kotka
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Finland
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Kuopio
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Finland
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Oulu
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Finland
State/province [37] 0 0
Turku
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Germany
State/province [38] 0 0
Baden-Württemberg
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Berlin
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Hungary
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Baja
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Bekescsaba
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Budapest
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Debrecen
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Komarom
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Szeged
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Westmeath
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Almere
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Amsterdam
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Fredrikstad
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Nesttun
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Oslo
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Stavanger
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Bialystok
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Lublin
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Szczecin
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Warszawa
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Portugal
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Coimbra
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Lisboa
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Slovakia
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Bratislava 2
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Slovakia
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Hlohovec
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Lucenec
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Slovakia
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Nitra
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Slovakia
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Velky Krtis
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Madrid
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Sevilla
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Valencia
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Álava
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Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
State/province [95] 0 0
Hampshire
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03240523