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    Summary
    EudraCT Number:2014-002832-15
    Sponsor's Protocol Code Number:49916
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-002832-15
    A.3Full title of the trial
    Ulipristal versus Gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy: a double blind randomized controlled trial
    Ulipristal versus Gonadotropine-releasing hormoon agonists voorafgaand aan laparoscopische myoomenucleatie: een dubbelblind gerandomiseerd onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ulipristal versus Gonadotropin-releasing hormone agonists prior to laparoscopic fibroid removal: a double blind randomized controlled trial
    Ulipristal versus Gonadotropine-releasing hormoon agonists voorafgaand aan laparoscopische myoom verwijdering: een dubbelblind gerandomiseerd onderzoek
    A.4.1Sponsor's protocol code number49916
    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 SponsorVU university medical center
    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 supportGedeon Richter
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU university medical center
    B.5.2Functional name of contact pointDept of gynaecology
    B.5.3 Address:
    B.5.3.1Street Addressde Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204444444
    B.5.6E-mailw.hehenkamp@vumc.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 Esmya
    D.2.1.1.2Name of the Marketing Authorisation holderGedeon Richter
    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 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.3.8INN - Proposed INNulipristalacetate
    D.3.9.1CAS number 126784-99-4
    D.3.9.3Other descriptive nameULIPRISTAL ACETATE
    D.3.9.4EV Substance CodeSUB30470
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Lucrin
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie B.V.
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uterine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard which removes the fibroids entirely, preferably laparoscopically because of a faster recovery and cosmetical benefits, although the succes of a laparoscopic approach is dependent on the size of the fibroid(s) and the difficulty of dissection.
    Myomen van de uterus komen veel voor. Het toepassen van een myoomenucleatie is de gouden standaard: alleen hiermee worden het myoom (de myomen) volledig verwijderd. Minimaal invasieve behandelingen worden steeds vaker toegepast. De laparoscopische myoomenucleatie wordt bij voorkeur uitgevoerd ivm het voordeel voor de patient ten aanzien van herstel en cosmetisch resultaat. Het succes van laparoscopisch opereren wordt echter bepaald door de grootte van het myoom en het chirurgische klievingsvlak.
    E.1.1.1Medical condition in easily understood language
    Uterine fibroids are very common. Sometimes removal is necessary, preferably by laparoscopy, although this is only possible when the fibroids are not too big.
    Myomen (vleesbomen) van de baarmoeder komen veel voor. Soms is het noodzakelijk om deze myomen te verwijderen, bij voorkeur met een kijkoperatie, maar dan kan alleen als de myomen niet te groot zijn.
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10046784
    E.1.2Term Uterine fibroids
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In order to increase the success rate of a laparoscopic procedure pre-treatment to decrease the volume might be beneficial. Gonadotropin-releasing hormone agonists (GnRHa) are used for this purpose with good results in terms of volume reduction, but sometimes resulting in loss of distinction of the right surgical planes and side effects (hot flushes) for the patient. Ulipristal is a new pre-operative treatment option for symptomatic fibroids, which has demonstrated good results in terms of volume reduction. The effect on cleavage planes is unknown. In this study Ulipristal will be compared to the gold standard: GnRH analogues in order to pre-treat fibroids that will be removed by laparoscopic myomectomy.
    Om een laparoscopische benadering mogelijk te maken, danwel te vergemakkelijken is voorbehandeling raadzaam. Hiervoor werd altijd GnRH analogen gebruikt. Nadeel van dit middel is echter de bijwerkingen (opvliegers) en het mogelijk bemoeilijkte klievingsvlak. Sinds kort is een nieuw geneesmiddel voor deze indicatie geregistreerd: Ulipristal acetaat waarbij minder bijwerkingen zijn beschreven. Het effect op chirurgische uitkomsten en de vergelijking met GnRH is echter nog niet bekend. Dit onderzoek vergelijkt Ulipristal met de gouden standaard GnRH analogen als voorbehandeling voor een laparoscopische myoomenucleatie.
    E.2.2Secondary objectives of the trial
    Furthermore the following outcomes will be investigated: volume reduction, surgical time, surgical ease, complications, quality of life, satisfaction and costs.
    Naast de primaire uitkomst zullen de volgende uitkomsten worden onderzocht: volumereductie van de myomen, operatie duur, chirurgisch gemak, complicaties, kwaliteit van leven, tevredenheid en kosten.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: pre-treatment versus no pre-treatment prior to laparoscopic myomectomy: a non-randomized comparison.
    Date: same as general protocol
    Version: 1
    Objectives: same objectives as main study (pre-treatment versus no-pre-treatment)
    Methods: Eligible patients that are not willing to participate in the trial will not be pre-treated, or will be treated with the gold standard: GnRHa. Those patients that choose not to be pre-treated will be asked to participate in the untreated, not-randomized control group and will (after informed consent) follow the same study flow as the randomized patients. This way, pre-treatment in general can be compared to no pre-treatment.
    Titel: voorbehandeling versus geen voorbehandeling voor laparoscopische myoomenucleatie: een niet-gerandomiseerde vergelijking.
    datum: zelfde als algemeen protocol
    Versie: 1
    Obejctive: zelfde objectives als primaire studie (maar dan wel voorbehandeling versus geen voorbehandeling).
    Methode: Geschikte patienten die niet willen deelnemen aan de studie zullen ofwel geen voorbehandeling krijgen, ofwelk behandeld worden met de gouden standaard: GnRHa. De patienten die ervoor kiezen helemaal geen voorbehandeling te krijgen zullen gevraagd worden om deel te nemen aan de studie in de niet-voorbehandelde, niet-gerandomiseerde controle groep. Zij zullen (na tekenen van informed consent) dezelfde studie-flow volgen als de gerandomiseerde patienten (met uitzondering van de voorbehandeing). Op deze manier kan voorbehandeling in het algemeen ook worden vergeleken met geen voorbehandeling.
    E.3Principal inclusion criteria
    Women visiting the gynecological outpatient department with symptomatic fibroids will be screened for eligibility. In order to be eligible to participate in this trial, a subject must meet all of the following criteria:
     provide written consent prior to any study related procedures
     pre-menopausal
     a planned resection of a maximum of 2 FIGO (PALM-COEIN classification)
    type 3, 4, 5, 6 or 2-5 fibroids of >5 cm
     the(se) fibroid(s) should be between 5 and 12 cm (maximum diameter)
     other fibroids should be small (<2 cm), not clinically relevant, or not resectable
    (e.g. difficult position), or type 7 (any size)
     eligible for laparoscopic myomectomy
    Vrouwen met symptomatische myomen gezien op de polikliniek gynaecologie die in aanmerking komen voren een myoomenucleatie worden gescreend op geschiktheid.
    Inclusie criteria zijn voor deelname aan het onderzoek zijn:
     geschreven en mondeling consent kunnen geven voor deelname
     pre-menopauzaal
     geplande myoom enucleatie laparoscopisch van maximaal 2 myomen FIGO
    (PALM-COEIN classification) type 3, 4, 5, 6 or 2-5 fibroids of >5 cm
     diameter tussen de 5 en 12 cm (maximum diameter)
    andere myomen mogen niet groter zijn dan 2 cm, niet klinisch relevant of
    niet reseceerbaar (moeilijke positie of type 7 (any size)
     geschikt voor laparoscopische myoom enucleatie
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this trial:
     pregnancy
     (suspicion of) malignancy
     any type 0-2 fibroids smaller than 5 cm
     more than 2 type 3-6 fibroids > 5 cm that need to be removed (except type 7
    fibroids of any size)
     use of any hormonal agents and not willing to discontinue their use
     use of anticoagulants
     coagulopathy
     Use of NSAIDs impacting bleeding before surgery
     Contraindication to laparoscopy procedure or causes of complications
    (multiple laparotomies, frozen pelvis, severe endometriosis)
     allergy to leuprolide acetate/comparable nonapeptides or Ulipristal



    Voornaamste exclusie criteria:
     zwangerschap
     (verdenking op) maligniteit
     aanwezigheid ype 0-2 myoom <5 cm
     meer dan 2 type 3-6 myomen >5 cm die verwijderd moeten worden, behalve type
    7 myoom ongeacht de afmeting
     gebruik van hormonale medicatie en onbereidheid deze te staken
     gebruik anti-stolling
     coagulopathie
     gebruik van NSAIDs (bloedings neiding beinvloedend) voorafgaand aan de operatie
    contra-indicatie voor laparoscopie (meerder laparotomieen in VG, frozen
    pelvis, graad IV endometriose)
     allergie leuprolide acetate/comparable nonapeptides or Ulipristal
    E.5 End points
    E.5.1Primary end point(s)
    In this study it will be investigated if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome).
    Dit onderzoek wordt uitgevoerd om te beoordelen of voorbehandeling met ulipristal non-inferior is ten op zichte van GnRHa met betrekking tot per-operatief bloedverlies (primaire uitkomst maat).
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be reached when the last patient is operated on. This will be around 4 months after inclusion of the last patient, since pre-treatment takes 3 months, after which surgery will take place within a month.
    Dit eindpunt zal bereikt worden wanneer de laatste patient is geopereerd. Dat zal ongeveer 4 maanden na de laatste randomisatie zijn, aangezien de voorbehandeling 3 maanden in beslag neemt en de operatie binnen een maand na het einde van de voorbehandeling zal plaatsvinden.
    E.5.2Secondary end point(s)
    Furthermore the following outcomes will be investigated: volume reduction, surgical time, surgical ease, complications, quality of life, satisfaction and costs.
    Naast de primaire uitkomst zullen de volgende uitkomsten worden onderzocht: volumereductie van de myomen, operatie duur, chirurgisch gemak, complicaties, kwaliteit van leven, tevredenheid en kosten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The last endpoint will be obtained with the last questionnaire 6 months after treatment.
    Het laatste eindpunt zal 6 maanden na de behandeling worden verkregen door een vragenlijst.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    De trial is officially ended when the last questionnaire at six months follow up is returned.
    De studie is beeindigd wanneer de laatste vragenlijst 6 maanden na de behandeling is teruggestuurd.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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.1.2.1Number of subjects for this age range: 99
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 99
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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