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    Summary
    EudraCT Number:2017-003144-21
    Sponsor's Protocol Code Number:NL62764.018.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003144-21
    A.3Full title of the trial
    Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery.
    Kosteneffectiviteit van perioperatief gebruik van topicale oestrogenen bij postmenopauzale vrouwen die vaginale prolapsoperatie ondergaan.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research into effectiveness and costs concerning the use of (vaginally administered) oestrogen before and after vaginal prolapse surgery, in women after menopause.
    Onderzoek naar de effectiviteit en kosten van vaginale oestrogeencrème bij vrouwen na de menopauze die een verzakkingsoperatie ondergaan
    A.3.2Name or abbreviated title of the trial where available
    EVA
    EVA
    A.4.1Sponsor's protocol code numberNL62764.018.17
    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 SponsorBoard of Directors, Academic Medical Centre
    B.1.3.4CountryNetherlands
    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'Leading the Change' program of Stichting Zorgevaluatie
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNVOG Consortium
    B.5.2Functional name of contact pointTrial bureau
    B.5.3 Address:
    B.5.3.1Street AddressP.O. box 22660
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100DD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205663857
    B.5.6E-mailinfo@studies-obsgyn.nl
    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 Yes
    D.2.1.1.1Trade name Synapause
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Vaginal cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal 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 Yes
    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 placeboVaginal cream
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pelvic organ prolapse
    Vaginale prolaps
    E.1.1.1Medical condition in easily understood language
    Female genitale prolapse
    Vaginale verzakking
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10046940
    E.1.2Term Vaginal prolapse
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study aims to comprehensively compare the effectiveness and costs of perioperative topical oestrogen for postmenopausal women undergoing pirmairy POP surgery. In this trial, the perioperative use of oestrogen is considered superior to placebo which results in cost reduction.

    Deze studie streeft naar een uitgebreide vergelijking van de effectiviteit en de kosten van perioperatieve (vaginale) toediening van oestrogeencrème bij postmenopauzale vrouwen die primaire prolapschirurgie ondergaan. In deze studie wordt het perioperatieve gebruik van oestrogeen als superior aan placebo beschouwd, wat zal resulteren in kostenreductie op de lange termijn.
    E.2.2Secondary objectives of the trial
    Investigate adverse effects and reasons for the discontinuation of treatment.
    Onderzoeken van nadelige effecten en redenen voor de beëindiging van de behandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Postmenopausal women (>1 year amenorrhoea) with a minimum age of 18 years old
    - Pelvic organ prolapse; POP Quantification stage 2 or higher
    - Women that will undergo primary POP surgery with native tissue repair; including at least anterior OR posterior vaginal wall repair.
    - Postmenopauzale vrouwen (> 1 jaar amenorroeduur) met een minimumleeftijd van 18 jaar
    - Prolaps; POP-Q stadium 2 of hoger
    - Vrouwen die primaire prolapschirurgie ondergaan; waarvan tenminste een voorwandplastiek OF achterwandplastiek
    E.4Principal exclusion criteria
    - Previous POP surgery in concerning compartment
    - Prolapse repair using mesh
    - Current vaginal infection
    - Use of oestrogens in the past 12 months
    - Contraindication for use of topical oestrogen
    - Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast cancer, endometrial cancer);
    - Insufficient knowledge or understanding of the Dutch language
    - Reeds operatieve correctie ondergaan voor een verzakking in hetzelfde compartiment.
    - Indicatie voor prolapschirurgie met mesh
    - Aanwezigheid van vaginale infectie
    - Gebruik van oestrogenen in de afgelopen 12 maanden
    - Contra-indicatie voor topicaal oestrogeen gebruik
    - Doorgemaakt, bekend met, of verdenking van oestrogeenafhankelijke kwaadaardige tumoren (bijvoorbeeld borstkanker, baarmoederkanker);
    - Onvoldoende beheersing of begrip van de Nederlandse taal.
    E.5 End points
    E.5.1Primary end point(s)
    Subjective cure (PGI-I)
    Subjectieve genezing (PGI-I)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint 1: baseline (4-6 weeks preoperative)
    Timepoint 2: 3 months postoperative
    Timepoint 3: 12 months postoperative
    Tijdspunt 1: baseline (4-6 weken preoperatief)
    Tijdspunt 2: 3 maanden postoperatief
    Tijdspunt 3: 12 maanden postoperatief
    E.5.2Secondary end point(s)
    - Compound measure:
    [1] no prolapse in compartment of surgery or past the hymen
    [2] no bothersome complaints of prolapse
    [3] no re-intervention for prolapse in the compartment of surgery within the follow-up period;
    - QALY (EQ-5D-6L);
    - Disease specific quality of life: micturition, defecation and sexual function;
    - Vaginal pH;
    - Signs of vaginal atrophy during gynaecological examination;
    - Complaints of vaginal atrophy;
    - Morbidity and adverse events;
    - Interventions for pelvic floor pathology;
    - Costs;
    - Adherence to treatment.
    - Samengestelde uitkomstmaat:
    1] Geen prolaps in geopereerde compartiment tot of voorbij het hymen.
    2] Geen hinderlijke prolapsklachten.
    3] Geen re-interventie vanwege prolaps in het geopereerde compartiment tijdens follow up.
    - QALY (EQ-5D-6L);
    - Ziekte specifieke kwaliteit van leven: mictie, defecatie, seksuele functie;
    - Vaginale pH;
    - Tekenen van vaginale atrofie tijdens gynaecologisch onderzoek
    - Klachten van vaginale atrofie;
    - Morbiditeit en bijwerkingen;
    - indicatie voor vervolg behandeling vanwege bekkenbodem gerelateerde aandoeningen;
    - Kosten;
    - Therapietrouw.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint 1: baseline (4-6 weeks preoperative)
    Timepoint 2: 3 months postoperative (adherence to treatment)
    Timepoint 3: 6 months postoperative (adherence to treatment)
    Timepoint 4: 12 months postoperative
    Tijdspunt 1: baseline (4-6 weken preoperatief)
    Tijdspunt 2: 3 maanden postoperatief (therapietrouw)
    Tijdspunt 3: 6 maanden postoperatief (therapietrouw)
    Tijdspunt 4: 12 maanden postoperatief
    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 No
    E.6.4Safety No
    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 No
    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 concerned33
    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 Yes
    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
    Laatste bezoek van de laatst deelnemende patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 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 state300
    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)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NVOG Consortium 2.0
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
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