Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-021036-33
    Sponsor's Protocol Code Number:P-AG-E-3
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-26
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-021036-33
    A.3Full title of the trial
    Double-blind comparison of VAC BNO 1095 FCT with placebo to identify dose dependent effects in patients suffering from cyclic mastodynia and PMS
    A.3.2Name or abbreviated title of the trial where available
    Dose dependent effects of VAC BNO 1095 on cyclic mastodynia and PMS
    A.4.1Sponsor's protocol code numberP-AG-E-3
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBionorica SE
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code VAC BNO 1095 10 mg (FCT)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000042219
    D.3.9.2Current sponsor codeVAC BNO 1095
    D.3.9.3Other descriptive namevitex agnus castus dry extract
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cyclic mastodynia and PMS
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Identification of the optimal dosage of VAC BNO 1095 FCT for treatment of cyclic mastodynia and PMS
    To prove the efficacy of VAC BNO 1095 FCT in the treatment of cyclic mastodynia
    E.2.2Secondary objectives of the trial
    n.a.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females aged 18 to 45 who have signed an ICF at screening visit S-2 at the latest.
    2. Subject has a history of cyclic mastodynia and PMS
    3. Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2.
    4. At screening visit S-2 subject is reporting at least one physical PMS symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the COPE symptom list
    5. At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the COPE symptom list
    6. In both run-in cycles:
    6A. VAS ≥ 50 mm at least on one of the days of the late luteal phase
    6B. Cyclic course of the mastodynia, i.e. VAS in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 5 daily recordings)
    6C. PMS sum score resulting from COPE must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1)
    6D. at least one physical PMS symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present
    6E. PMS sum score resulting from COPE must not exceed 10 at day 4 of the menstruation
    6F. PMS sum score resulting from COPE must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10)
    7. Compliance for keeping detailed symptom records can be expected.
    8. Subject provides a negative pregnancy test at study start (if of childbearing potential) and uses a double-barrier hormone-free medically acknowledged contraception during the whole course of study (condom with jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), or a hormone-free intra uterine device.
    9. An unsuspicious breast USG/ mammogram not older than 12 months ruling out signs of malignancy
    E.4Principal exclusion criteria
    1. Proof of PMDD according to DSM-IV criteria as defined by APA based on the findings as follows :
    A total of at least 5 premenstrual symptoms with at least one severe mood symptom must be present. The instrument used for retrospective assessment will be a questionnaire according to DSM-IV criteria.
    In addition, the symptoms
    − must have a history of 1-year duration
    − must seriously interfere with work, relationships or social activities
    − must not be an exacerbation of another disease
    2. Intake of any of the following medications before treatment start (visit S-2
    up to visit V0) and within 6 months prior to visit S-2:
    o any treatment for mastodynia or premenstrual complaints
    o sexual hormones, combinations and inhibitors
    o pituitary hormones and their inhibitors
    o hypothalamic hormones
    o neuroleptics, antidepressants
    o serotonin-reuptake-inhibitors
    o prolactin-inhibitors or prolactin stimulating preparations
    o NSAIDs or any other analgetics including antirheumatics
    o spironolactone
    o androgens
    o gonadotrophin inhibitors
    o diuretics
    o danazol
    o psychotropic agents
    3. Any psychiatric treatment before treatment start (visit S-2 up to visit V0) and within 12 months prior to visit S-2.
    4. Medical history or presence of any of the following medical conditions/ diseases such as
    o Uncontrolled diabetes mellitus
    o Uncontrolled hypertension or any other uncontrolled disease or condition at the discretion of the investigator
    o Known hyperprolactinemia (> 50 ng/ml or > 1250 IU/ml)
    o Known hypo-/hyperthyreosis
    o Known hypo-/hyperparathyroidism
    o Known pituitary tumor including prolactinoma
    o Known chronic kidney disease
    o Known gastrointestinal, or liver diseases, such as:
    a. active peptic gastric ulcer
    b. malabsorption
    c. hepatitis
    o endometriosis
    o breast cancer, fibroadenoma, intraductal papilloma
    o suspicious non-verified finding on any breast ultrasound or mammograms in the past
    o galactorrhea of degree II or III
    o purulent or bloody nipple discharge
    o refractory and/or unverified breast skin- or nipple/areola lesions
    o pregnancy, lactation
    o wish for pregnancy
    o any surgery planned to take place during the trial including breast
    cyst puncture
    5. Values of safety laboratory parameters outside normal ranges and clinically relevant as assessed by the investigator
    6. Parallel participation in another clinical study, participation in another study within less than 6 weeks prior to study entry at S-2, or previous participation in the same study.
    7. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    8. Evidence of an uncooperative attitude
    9. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
    10. Patients in custody by judicial or official order.
    11. Patients who have difficulties in understanding the language in which the patient information is given.
    12. Patients who are members of the staff of the study centre, staff of the sponsor or CRO, the investigator herself or close relatives of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Change in maximum severity of cyclic breast pain (cyclic mastodynia) from Baseline (late luteal phase of 2nd run-in cycle) to V3 (late luteal phase of the 3rd treatment cycle under study medication). The severity of cyclic breast pain will be self- assessed by the patient on a Visual Analogue Scale (VAS).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=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 state180
    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)
    either lower dosage of same active substance (Agnucaston 4 mg, MA granted in CR) or alternative herbal or hormonal treatment
    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 Decision2010-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-10
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 18:17:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA