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    Summary
    EudraCT Number:2011-005333-39
    Sponsor's Protocol Code Number:WS982821
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-21
    Trial 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 ConcernedGreece - EOF
    A.2EudraCT number2011-005333-39
    A.3Full title of the trial
    The effects of acute sildenafil administration on inflammatory markers in patients with vasculogenic erectile dysfunction.
    Η οξεία επίδραση της σιλδεναφίλης σε φλεγμονώδεις δείκτες σε ασθενείς με αγγειακής αιτιολογίας στυτική δυσλειτουργία.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    Δεν υπάρχει
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    Δεν υπάρχει
    A.4.1Sponsor's protocol code numberWS982821
    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 SponsorNational and Kapodistrial University of Athens
    B.1.3.4CountryGreece
    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 supportPfizer Hellas S.A.
    B.4.2CountryGreece
    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.2.1.1.1Trade name Viagra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameViagra
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    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
    vasculogenic erectile dysfunction
    στυτική δυσλειτουργία αγγειακής αιτιολογίας
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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 evaluate the acute effects of sildenafil in ED patients and to estimate the time-effect of sildenafil administration in inflammatory markers in blood.
    Να αξιολογηθούν οι οξείες επίπτώσεις της σιλδεναφίλης στους δείκτες φλεγμονής και έπειτα να προβλεφθεί το χρονικό διάστημα μεταβολής των δεικτών φλεγμονής στο αίμα μετά την χορήγηση της.
    E.2.2Secondary objectives of the trial
    Safety and tolerance
    Ασφάλεια και ανεκτικότητα
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In the initial sub-study (pilot study) only 7 patients will be included to which inflammatory markers will be measured 1,2, 4 and 8 hours after sildenafil or placebo administration in order to determine the 2 post-administration time points with the greatest change at inflammatory markers.
    Αρχικά θα πραγματοποιηθεί μια πιλοτική μελέτη (υπομελέτη) σε 7 ασθενείς μόνο, στους οποίους οι φλεγμονώδεις δείκτες θα μετρώνται 1, 2, 4 ώρες και 8 ώρες μετά τη χορήγηση της σιλδεναφίλης ή του εικονικό φάρμακο, για τον εντοπισμό των δύο χρονικών σημείων μετά την χορήγηση με τις σημαντικότερες μεταβολές στα επίπεδα των δεικτών φλεγμονής στο αίμα.
    E.3Principal inclusion criteria
    (i) Patients with ED of vasculogenic origin which will be diagnosed according to comprehensive medical and sexual history (including psychiatric evaluation), physical examination, score of the five-item form of the International Index of Erectile Function, the Sexual Health Inventory for Men (SHIM score, <21 indicating ED), hormonal testing (total testosterone and prolactin) and penile Doppler ultrasonography. Vasculogenic ED will be diagnosed when the peak systolic velocity is less than 35 cm/s, and/or when the end-diastolic velocity is greater than 5 cm/s. Through these evaluations, patients will be excluded if their ED was secondary to hormonal, psychological, neurological, or anatomic abnormalities, pelvic surgery, or trauma
    (ii) Age 30-70 years old
    (iii) Clinically stable with no apparent ischemic disease. Evaluation of the subjects in order to rule out significant coronary artery disease will include a complete medical history and examination, measurements of blood pressure and heart rate, standard laboratory tests, a 12-lead electrocardiogram and an exercise test
    (iv) Willing to provide informed consent
    1. Ασθενείς με στυτική δυσλειτουργία αγγειακής αιτιολογίας, οι οποίοι θα διαγνωστούν βάση πλήρους ιατρικού και σεξουαλικού ιστορικού (καθώς και ψυχιατρικής εκτίμησης), φυσικής εξέτασης, εκτίμησης της κλίμακας SHIM (SHIM score, <21 υποδεικνύει στυτική δυσλειτουργία), ορμονικό έλεγχο (ολική τεστοστερόνη και προλακτίνη) και υπερηχητικό Doppler της πεΐκής αρτηρίας. Η αγγειακής αιτιολογίας στυτική δυσλειτουργία θα διαγιγνώσκεται όταν η μέγιστη συστολική ταχύτητα είναι μικρότερη των 35 cm/s και/ή όταν η τελοδιαστολική ταχύτητα είναι μεγαλύτερη των 5 cm/s. Μέσω αυτών των εκτιμήσεων οι ασθενείς θα αποκλειστούν σε περίπτωση δευτερεύουσας στυτικής δυσλειτουργίας λόγω ορμονικών, ψυχολογικών, νευρολογικών αιτιών ή λόγω ανατομικών ανωμαλιών, πυελικού χειρουργείου ή τραύματος
    2. Ηλικία 30 – 70 ετών
    3. Κλινικά σταθεροί ασθενείς χωρίς έκδηλη ισχαιμική νόσο. Η εκτίμηση των ασθενών για να αποκλειστεί πιθανή στεφανιαία νόσος θα περιλαμβάνει ένα εκτεταμένο ιατρικό ιστορικό, φυσική εξέταση, μέτρηση της αρτηριακής πίεσης, τυπικές εργαστηριακές εξετάσεις, ηλεκτροκαρδιογράφημα 12 απαγωγών και μία δοκιμασία ισχαιμίας.
    4. Ασθενείς που είναι πρόθυμοι να παράσχουν έγγραφη συγκατάθεση
    E.4Principal exclusion criteria
    (i) Diabetic patients. Diagnosis of diabetes is based on fasting glucose levels >125mg/dl (>7.0mmol/l) or use of antidiabetic treatment
    (ii) Left ventricular ejection fraction≤40%
    (iii) Contraindications to sildenafil use e.g. nitrate use within 24 hours
    (iv) History of sildenafil intolerance
    (v) Primary lung disease and/or COPD
    (vi) Severe hepatic or renal failure
    (vii) Severe valvular disease
    (viii) Unstable arrhythmia
    (ix) Malignancy
    (x) Systemic inflammatory diseases and autoimmune diseases
    (xi) Corticosteroid, non-steroid anti-inflammatory drug therapy or proven anti-inflammatory regimens such as methotrexate. Any other medication will be recorded.

    1. Διαβητικοί ασθενείς. Η διάγνωση του διαβήτη θα τίθεται αν η γλυκόζη νηστείας είναι >125 mg/dl (>7.0 mmol/l) ή γίνεται χρήση αντιδιαβητικών φαρμάκων.
    2. Κλάσμα εξώθησης αριστερής κοιλίας≤40%
    3. Αντενδείξεις χρήσης σιλδεναφίλης π.χ. χρήση νιτρωδών το τελευταίο 24ωρο
    4. Ιστορικό δυσανεξίας στη σιλδεναφίλη
    5. Πρωτοπαθή πνευμονική νόσο ή/και χρόνια αποφρακτική πνευμονοπάθεια
    6. Σοβαρού βαθμού νεφρική ή ηπατική ανεπάρκεια
    7. Σοβαρού βαθμού βαλβιδική νόσος
    8. Ασταθής αρρυθμία
    9. Κακοήθεια
    10. Συστηματική φλεγμονώδης νόσος ή αυτοάνοσο νόσημα
    11. Χρήση κορτικοστεροειδών, μη στεροειδών αντιφλεγμονωδών φαρμάκων ή σκευασμάτων αποδεδειγμένης αντιφλεγμονώδους δράσης, όπως η μεθοτρεξάτη. Όλα τα υπόλοιπα φάρμακα θα καταγράφονται.
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measures will be the changes in blood inflammatory markers at point 1 and point 2 post administration of sildenafil, which will be determined according to the results of the pilot study (it is anticipated that it will be approx 8 hours).
    Τα κύρια τελικά σημεία θα είναι οι μεταβολές των δεικτών φλεγμονής στο αίμα στο σημείο 1 και στο σημείο 2 μετά τη χορήγηση της σιλδεναφίλης, που θα καθοριστουν ανάλογα με τα αποτελέσματα της πιλοτικής μελέτης (αναμένεται ότι θα είναι περίπου 8 ώρες).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be defined from the initial sub-study
    Θα ορισθούν απο την αρχική υπο-μελέτη
    E.5.2Secondary end point(s)
    Secondary outcome will be the time-effect of sildenafil on blood inflammatory markers.
    Δευτερεύον τελικό σημείο θα είναι η επίδραση της διάρκειας της θεραπείας (time-effect) με σιλδεναφίλη στους δείκτες φλεγμονής του αίματος.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will be defined from the initial sub-study
    Θα ορισθούν απο την αρχική υπο-μελέτη
    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.8.3 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 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
    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 months0
    E.8.9.1In the Member State concerned 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) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state31
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 31
    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)
    The GP will inform the patient for additional therapeutic options and he/she could administer to the patient his initial treatment
    Ο θεράπων ιατρός θα μιλήσει στον ασθενή για περαιτέρω θεραπευτικές επιλογές και μπορεί να χορηγήσει την αρχική φαρμακευτική αγωγή
    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 Decision2012-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-17
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