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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2012-005042-37
    Sponsor's Protocol Code Number:P-AG-E-4
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-005042-37
    A.3Full title of the trial
    Prospective, double-blind, placebo-controlled, parallel-group, multi-centre randomized clinical trial to proof efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT in patients suffering from cyclic mastodynia and PMS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of chaste tree extract with the name "VAC BNO 1095 10 mg FCT" (20 mg daily) on cyclic breast pain and premenstrual syndrome
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT on cyclic mastodynia and PMS
    A.4.1Sponsor's protocol code numberP-AG-E-4
    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 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 supportBionorica SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBionorica SE
    B.5.2Functional name of contact pointSenior Clinical Research Physician
    B.5.3 Address:
    B.5.3.1Street AddressKerschensteinerstraße 11-15
    B.5.3.2Town/ cityNeumarkt
    B.5.3.3Post code92318
    B.5.3.4CountryGermany
    B.5.4Telephone number004991812137061
    B.5.5Fax number0049918121367061
    B.5.6E-maileugen.baumgaertner@bionorica.de
    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 nameVAC BNO 1095 10 mg FCT
    D.3.2Product code VAC BNO 1095 10 mg FCT
    D.3.4Pharmaceutical form Film-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.3.9.1CAS number 8000042-21-9
    D.3.9.2Current sponsor codeVAC BNO 1095 10 mg FCT
    D.3.9.3Other descriptive nameVITEX AGNUS CASTUS dry extract
    D.3.9.4EV Substance CodeSUB15711MIG
    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) 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 Yes
    D.3.11.9Recombinant medicinal product No
    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
    E.1.1.1Medical condition in easily understood language
    Cyclic breast pain and premenstrual syndrome
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    To prove the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT in the treatment of cyclic mastodynia.
    E.2.2Secondary objectives of the trial
    not applicable
    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 at visit S-2
    3. Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2 and during run in phase
    4. At screening visit S-2 subject is reporting at least one physical PMS symptom (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 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 7 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 7 daily recordings)
    6C. At least one physical PMS symptom and one psychic symptom is present on at least one day of the late luteal phase.
    6D. PMS sum score resulting from COPE in the mid follicular phase (sum score of all PMS sum scores across the seven-day phase) is less than 75 % of the PMS sum score resulting from COPE in the late luteal phase (sum score of all PMS sum scores across the seven-day phase)
    7. Compliance for keeping detailed symptom records can be expected
    8. Subject provides a negative pregnancy test at study start (S-2, V0 and V3 if of childbearing potential) and is willing to use one of the following hormone-free medically acknowledged contraception methods with a PEARL-index < 1 % from enrolment till onset of next menses after study termination:
    • Double-barrier method, e.g. condom* AND occlusive cap (diaphragm or Portio cap or Lea Contraceptivum) with spermicidal foam/gel/film/cream/suppository (* A female condom and a male condom should not be used together as friction between the two can result in either product failing.), OR
    • hormone-free intra uterine device (IUD) AND condom, OR
    • hormone-free IUD AND sponge, OR
    • hormone-free IUD AND spermicidal foam/gel/film/cream/suppository OR
    • vasectomized partner OR
    • sexual abstinence
    Non childbearing potential group is defined for the intended patient as surgical sterilisation at least three months before the start of the study
    9. An unsuspicious breast USG/mammogram not older than 12 months ruling out signs of malignancy is available (otherwise arrange breast USG prior to visit S-1, exceptionally prior to V0)
    E.4Principal exclusion criteria
    1. Hypersensitivity to the active substance or to any of the excipients of the IMP at visit S-2
    2. Proof of PMDD at visit S-2 according to DSM-IV criteria as defined by APA [American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders , 4th ed. Text Revision. Washington, DC: American Psychiatric Association, 2000] 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
    3. 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:
    • hypothalamic hormones
    • injectable contraceptives: 3-month injection
    4. Intake of any of the following medications (including herbal or homeopathic drugs) before treatment start (visit S-2 up to visit V0) and within 3 months prior to visit S 2 (with exception of hypothalamic hormones and 3-monthly injectable contraceptives: within 6 months prior to visit S-2):
    • any treatment for mastodynia or premenstrual complaints
    • sexual hormones, combinations and inhibitors
    • pituitary hormones and their inhibitors
    • dopamine-agonists and dopamine-antagonists
    • neuroleptics, antidepressants (including serotonin- and serotonin-norepinephrine-reuptake-inhibitors)
    • prolactin-inhibitors or prolactin stimulating preparations
    • drug abuse or continuous intake of NSAIDs or any other analgetics including antirheumatics (up to 2 tablets of paracetamol 500 mg or equivalent per week are allowed)
    • spironolactone
    • gonadotrophin inhibitors
    • diuretics
    • danazol
    • psychotropic agents
    5. Any psychiatric treatment before treatment start (visit S-2 up to visit V0) and within 12 months prior to visit S-2
    6. Medical history or presence of any of the following medical conditions/ diseases before treatment start:
    • Uncontrolled diabetes mellitus: Patients with known diabetes mellitus, who have a glycosylated haemoglobin (HbA1c) ≥ 7% as assessed at visit S-1
    • Uncontrolled hypertension: Patients with a diastolic blood pressure > 90 mmHg at visit S-2
    • Known cardiac insufficiency, coronary heart disease, valvular heart disease, cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at visit S 2
    • Known clinically significant organ or systemic diseases or any other relevant medical condition such that in the opinion of the investigator, the significance of the disease or condition will compromise the subject’s participation in the study
    • Known hyperprolactinemia (serum prolactin basal > 50 ng/ml or > 1050 mlU/L)
    • Known hypo-/hyperthyreosis
    • Known hypo-/hyperparathyroidism
    • Known pituitary tumor including prolactinoma
    • Known chronic kidney disease
    • Known gastrointestinal, or liver diseases, such as:
    a. active peptic gastric ulcer
    b. malabsorption
    c. hepatitis
    • endometriosis
    • breast cancer, fibroadenoma, intraductal papilloma or other malignancy within the last 10 years
    • suspicious non-verified finding on any breast ultrasound or mammograms in the past
    • galactorrhea of degree II or III
    • purulent or bloody nipple discharge
    • refractory and/or unverified breast skin- or nipple/areola lesions
    • pregnancy, lactation
    • wish for pregnancy
    • any surgery planned to take place during the trial including breast cyst puncture
    7. Values of safety laboratory parameters outside normal ranges and clinically relevant as assessed by the investigator at S-1
    8. At screening: serum thyroid-stimulating hormone (TSH) ≥ 2.5 mU/l
    9. 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
    10. 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) at visit S-2
    11. Evidence of an uncooperative attitude (S-2)
    12. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study (S-2)
    13. Patients in custody by judicial or official order (S-2)
    14. Patients who have difficulties in understanding the language in which the patient information is given (S-2)
    15. 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 (S-2)
    E.5 End points
    E.5.1Primary end point(s)
    Maximum severity of cyclic breast pain (cyclic mastodynia) during the late luteal phase of the 3rd treatment cycle under Investigational Medicinal Product (IMP). The severity of cyclic breast pain will be self-assessed by the patient on a Visual Analogue Scale (VAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the end (late luteal phase) of the 3rd treatment cycle
    E.5.2Secondary end point(s)
    The secondary endpoints are defined as:
    1. Maximum severity of cyclic breast pain (cyclic mastodynia) during the late luteal phases of treatment cycles 1 and 2. The severity of cyclic breast pain will be self-assessed by the patient on a Visual Analogue Scale (VAS).
    2. Average severity of cyclic mastodynia, determined in the late luteal phase of each of the treatment cycles.
    3. Intensity of premenstrual syndrome (PMS) assessed by means of a premenstrual symptom diary (COPE = calendar of premenstrual experiences) during each of the treatment cycles.
    4. Overall assessments of efficacy on cyclic mastodynia and PMS by patient and investigator at study end (V3) by a score ranging from 1 to 5.
    5. Subgroup analysis:
    5A. Patients with the waist circumference ≤ 90 cm
    5B. Patients with the waist circumference > 90 cm
    For both subgroups 5A. and 5B.: Maximum severity of cyclic breast pain (cyclic mastodynia) during the late luteal phase of the 3rd treatment cycle under Investigational Medicinal Product (IMP). The severity of cyclic breast pain will be self-assessed by the patient on a VAS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During the end (late luteal phase) of the 1st and 2nd treatment cycle, respectively
    2. During the end (late luteal phase) of the 1st, 2nd and 3rd treatment cycle, respectively
    3. During the 1st, 2nd and 3rd treatment cycle, respectively
    4. Visit 3 (after treatment with IMP for 3 menstrual cycles)
    5. During the end (late luteal phase) of the 3rd treatment cycle
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months13
    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: 280
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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)
    After the subject has ended the participation in the trial the subject will be receiving the standard therapy according to the clinical picture. Treatment with VAC can be continued after the end of the study with a VAC preparation marketed as OTC product in Germany or Poland.
    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 Decision2013-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-28
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