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    Summary
    EudraCT Number:2016-002855-48
    Sponsor's Protocol Code Number:BAY1002670/15789
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-002855-48
    A.3Full title of the trial
    A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    Randomizované multicentrické klinické skúšanie s paralelnými skupinami zamerané na posúdenie účinnosti a bezpečnosti vilaprisanu u pacientok s myómami maternice
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids
    Posúdenie bezpečnosti a účinnosti vilaprisanu u pacientok s myómami
    maternice
    A.3.2Name or abbreviated title of the trial where available
    ASTEROID 5
    A.4.1Sponsor's protocol code numberBAY1002670/15789
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address"EU CTR"
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 1002670 coated tablet 2 mg 245
    D.3.2Product code BAY 1002670
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvilaprisan
    D.3.9.1CAS number 1262108-14-4
    D.3.9.2Current sponsor codeBAY 1002670
    D.3.9.3Other descriptive nameBAY 1002670
    D.3.9.4EV Substance CodeSUB31208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Leiomyoma
    E.1.1.1Medical condition in easily understood language
    Uterine fibroids, heavy menstrual bleeding
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10046784
    E.1.2Term Uterine fibroids
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10016628
    E.1.2Term Fibroids
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10022794
    E.1.2Term Intramural leiomyoma of uterus
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women, 18 years or older at the time of Visit 1
    2. 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
    3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
    4.Use of an acceptable non-hormonal method of contraception
    5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.
    E.4Principal exclusion criteria
    1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
    2. Hypersensitivity to any ingredient of the study drugs
    3. 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).
    4. 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
    5. Abuse of alcohol, drugs, or medicines (eg, laxatives)
    6. Undiagnosed abnormal genital bleeding
    7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
    E.5 End points
    E.5.1Primary end point(s)
    Amenorrhea (yes/no), defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    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 .
    E.5.2Secondary end point(s)
    1) Total volume of menstrual blood loss (assessed by MP).
    2) Number of bleeding days
    3) Amenorrhea (yes/no)
    4) Absence of bleeding (spotting allowed)
    5) Time to onset of controlled bleeding
    6) HMB responder rate
    7) Percent change in volume of largest fibroid compared to baseline (measured by MRI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Menstrual blood loss: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period
    2) Number of bleeding days: from Day 1 of the TP1 until the day before a new TP would start again following the last treatment period
    3) Amenorrhea (yes/no), defined as MBL < 2 mL during last 28 days of each TP
    4) Absence of bleeding during the last 28 days of the treatment
    5) Time to onset of controlled bleeding: the first day, for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is less than 80mL.
    6) HMB responder rate (Percentage of subjects with blood loss < 80mL per 28 days and 50% reduction compared to baseline
    7) Percent change in volume of largest fibroid compared to baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    3 treatment arms with vilaprisan: A1 - 3/1 regimen; A2 - 6/2 regimen; A3 - 3/2 regimen.
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA219
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Taiwan
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 766
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 561
    F.4.2.2In the whole clinical trial 766
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All pregnancies occurring during the treatment and follow-up periods will be followed for the outcome for both the mother and fetus/child (in a case of life birth) until first birthday of the child.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-25
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