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    Summary
    EudraCT Number:2004-004004-20
    Sponsor's Protocol Code Number:UI04/6748
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-004004-20
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo Controlled trial to test the efficacy of St John's Wort (Hypericum Perforatum) for Premenstrual Syndrome.
    A.3.2Name or abbreviated title of the trial where available
    Testing the efficacy of St John's Wort (SJW) as a treatment for PMS
    A.4.1Sponsor's protocol code numberUI04/6748
    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 SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Jarsin 450mg
    D.2.1.1.2Name of the Marketing Authorisation holderLichtwer Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSt John's Wort
    D.3.2Product code SJW
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNHypericin
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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) No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    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
    The 'premenstrual syndrome' is a cyclical condition occurring 7-10 days before the onset of menstruation, and is relieved at, or shortly after commencement of menstrual flow. The most commonly reported symptoms include breast tenderness, bloating and cognitive complaints, such as poor concentration, confusion and forgetfulness, as well as depression, anxiety, irritability, and mood swings.
    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 determine whether St John's Wort is more beneficial than placebo supplements in relieving symptoms of PMS, using both subjective (daily symtpom checklists and self reports of depression, impulsivity, agression and anxiety levels) and objective measures (blood tests to measure hormone, neurotransmitter and cytokine levels, and response bias measures from an emotional Stroop task).
    E.2.2Secondary objectives of the trial
    Secondary objectives include examining the relationship between serotonin levels, cytokine levels and PMS symptoms, determining whether there is a relationship between the use of SJW and both cytokine and serotonin levels and determining whether the symptom profiles of a clinical population are similar to, or differ from, those of self-referred research recruited women
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To qualify for inclusion in this study, a patient must satisfy all of the criteria listed below:

    1. Written informed consent has been obtained prior to enrolment in the study.
    2. The participant is female and aged between 18 and 45 years.
    3. The participant is of good health, which will be assessed by the clinic doctor.
    4. The participant has regular menstrual cycles, with a cycle length of 25-35 days.
    5. The participant has PMS defined by at least a 30% increase in symptoms in the
    luteal phase compared to the follicular phase.
    E.4Principal exclusion criteria
    Women will be excluded from the study for any of the following reasons:

    1. Taking prescribed medication for PMS.
    2. Taking OTC medication for PMS and unwilling to abstain for the duration of the
    trial.
    3. Using hormonal preparations, including oral contraception or Hormone
    Replacement Therapy (HRT)
    4. Is pregnant, planning pregnancy or lactating.
    5. Has known photosensitivity.
    6. Has depression or anxiety.
    7. Taking:
    • HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir)
    • HIV non-nucleoside reverse transcriptase inhibitors (efavirenz, nevirapine)
    • Warfarin
    • Cyclosporine
    • Oral contraceptives
    • Photoreactive agents
    • Anticonvulsants (carbamazepine, phenobarbitone, phenytoin)
    • Digoxin
    • Theophylline
    • Triptans (sumatriptan, naratriptan, rizatriptan, zolmitriptan, frovatriptan)
    • SSRIs (citalopram, fluoxetine, fluvoxamine, paroxetine, sertaline)
    • Psoralens, (oxsoralen, trisoralen, ciprofloxacin and tetracycline)
    • Lithium
    • Antipsychotic drugs
    • Neuroleptic drugs
    • Cimetidine
    • Oral corticosteroids
    • Thyroid hormones
    • Immunosuppressive agents.

    E.5 End points
    E.5.1Primary end point(s)
    The endpoint of the trial is the change in total premenstrual symptom scores on the daily PMS symptom checklist, with the secondary endpoints being the change in specific symptoms on the PMS symptom checklist, changes in aggression, impulsivity, depression, anxiety, cytokine, and serotonin levels.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    The trial will end when every participant has finished their ninth menstrual cycle, defined by the first day of the tenth bleed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 40
    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)
    SJW is available over the counter, so participants have easy access to the drug if they want to continue taking it.
    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 Decision2005-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-20
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