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    Summary
    EudraCT Number:2013-000798-59
    Sponsor's Protocol Code Number:0080CA001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-000798-59
    A.3Full title of the trial
    Phase III, open-label, multi-centre study to assess the pharmacodynamic (PD), pharmacokinetic (PK) and safety of Zoreline 3.6 mg goserelin subcutaneous implant (Novalon) in women with confirmed endometriosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III, open-label, multi-centre study to investigate the movement, effect and safety of Zoreline 3.6 mg goserelin implant (Novalon) injected under skin, in women with confirmed endometriosis
    A.3.2Name or abbreviated title of the trial where available
    Zoreline 3.6 mg goserelin subcutaneous implant (Novalon) in women with confirmed endometriosis
    A.4.1Sponsor's protocol code number0080CA001
    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 SponsorNovalon S.A
    B.1.3.4CountryBelgium
    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 supportNovalon S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovalon S.A
    B.5.2Functional name of contact pointGeert Winnen
    B.5.3 Address:
    B.5.3.1Street AddressRue Saint-Georges 5-7
    B.5.3.2Town/ cityLiege
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003243492822
    B.5.6E-mailgwinnen@mithra.com
    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 nameZoreline 3.6 mg goserelin
    D.3.4Pharmaceutical form Implant in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Implantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGOSERELIN
    D.3.9.1CAS number 65807-02-5
    D.3.9.4EV Substance CodeSUB07962MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Endometriosis
    E.1.1.1Medical condition in easily understood language
    Endometriosis is a common condition where tissue that behaves like the lining of the womb (the endometrium) is found outside the womb.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    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
    To assess the ability of Zoreline 3.6 mg SC implant to induce by Visit 7 (Day 29±1 day) of Cycle 1 at the latest and maintain up to Visit 14 (end of treatment; Day 85±2 days) oestradiol plasma suppression (≤30 pg/mL) in women with confirmed endometriosis
    E.2.2Secondary objectives of the trial
    •To assess general safety and acceptability of the drug and syringe combination in line with standard of care.
    •To characterize the goserelin plasma concentration profile (maximum plasma concentration [Cmax], time to reach Cmax [Tmax], minimum plasma concentration [Cmin], area under the plasma concentration-time curve [AUC]) from Visit 2 (Day 1) to Visit 7, from Visit 7 to Visit 12, and from Visit 12 to Visit 14, i.e. during three consecutive treatment cycles, and during follow-up period until Visit 15. The area under the curve will be extrapolated to infinity (AUC0-∞) and terminal (apparent elimination) half-life (t½) will be determined if possible.
    •To characterize the (Cmax, AUC) from Visit 2 (Day 1) to Visit 15 including initial flare between Visit 2 (Day 1) and Visit 7, time to achieve menopause level, acute or chronic phenomenon (surge at re-injection between Visit 8 (Day 30) and Visit 9 (Day 32) and potential escape (surge) from Visit 10 (Day 36±1 day) to Visit 14.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Premenopausal women aged between 18 and 45 years inclusive;
    2. Clinical diagnosis of endometriosis within the last 5 years and indicated for hormonal suppression therapy. Clinical diagnosis should be based on clinical symptoms of endometriosis (such as chronic pelvic pain, dyspareunia, cyclic intestinal pain [bloating/diarrhoea/constipation], uterine cramping in young females, severe dysmenorrhea, dyspareunia, ovulation pain, cyclical/menstrual symptoms with or without abnormal bleeding, infertility, chronic fatigue) confirmed by laparoscopy with or without histology and/or transvaginal/rectal ultrasound (bladder, ovarian or rectum locations) and/or enema studies (for deeply infiltrating endometriosis);
    3. Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs;
    4. Willing to provide informed consent in writing;
    5. Willing to use non-hormonal anti-conception method (male/female condom/copper intrauterine device [IUD]) from Screening (Visit 1; Day -28 to Day -4) till the end of treatment period (Visit 14; Day 85±2 days);
    6. Willing and able to attend the scheduled study visits and to comply with the study procedures;
    7. Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
    E.4Principal exclusion criteria
    1. Previous or current hormonal treatment for endometriosis, including GnRH receptor agonists, GnRH receptor antagonists, within 6 months prior to the screening visit;
    2. Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) or aspartate transaminase (AST)/serum glutamic oxaloacetic transaminase (SGOT) ≥2 x upper limit of normal (ULN);
    3. Moderate (stage 3B) or severe (stage 4 and 5) chronic kidney disease with an estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <45 mL/min/1,73 m2;
    4. Use of contraceptive treatments that interfere with oestradiol plasma level 1 week (or 5 half lives; whichever is longest) before IMP administration;
    5. Has endometriosis surgery scheduled for between the Screening and Enrolment visit. (Endometriosis surgery allowed following Visit 14 [Day 85±2 days]);
    6. Implanted progestin treatment should be released at least 1 month before study enrolment;
    7. Has received an investigational drug within the last 28 days before the Screening visit (Visit 1) or longer if considered to possibly influencing the outcome of this study;
    8. Has an unstable medical condition or chronic disease such as but not limited to neurological hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease;
    9. History or presence of any malignancy other than treated squamous cell/basal cell carcinoma of the skin within the last 5 years;
    10. Evidence (including clinically significant abnormal bilirubin and/or albumin values) or history of chronic hepatic disease;
    11. Have a repeatable prolongation of the QTc interval at screening (mean QTcB ≥450 ms); or personal or family history of long QT syndrome or significant risk factors of prolonged QT interval arrhythmias. (as determined by the investigator);
    12. Patient for which a possible loss in bone mass which in the judgment of the investigator would affect the patient's health;
    13. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the IMP;
    14. Other abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the study;
    15. Pregnancy (or willingness to become pregnant during the study) or breast-feeding during study period;
    16. Has an intellectual incapacity or inability to comprehend, precluding adequate understanding or co-operation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective will be considered as achieved if the lower limit of the 2-sided 95% CI on the responder rate is ≥90%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A responder is defined as a subject who reached plasma oestradiol levels below the menopause level (≤30 pg/mL) by Visit 7 (Day 29±1 day) at the latest and maintained plasma oestradiol levels below the menopause level (≤30 pg/mL) until Visit 14 (end of treatment; Day 85±2 days), except for :
    •Oestradiol level during the acute-on-chronic period from Visit 8 (Day 30) to Visit 9 (Day 32);
    •Oestradiol escape following the onset of suppression from Visit 10 (Day 36±1 day) to Visit 13 (Day 71±2 days) not confirmed at the next sampling day;
    •Oestradiol escape at Visit 14 (end of treatment; Day 85±2 days).
    E.5.2Secondary end point(s)
    Pharmacodynamics (PD):
     Plasma concentrations of oestradiol from Visit 2 (Day 1) to Visit 15 (as soon as possible after return of the patient’s menses or at the latest at Day 141±3 days) including initial flare between Visit 2 (Day 1) and Visit 7 (Day 29±1 day), time to achieve menopause level, acute or chronic phenomenon (surge(s) at re-injection) between Visit 8 (Day 30) and Visit 9 (Day 32) and potential escape (surge) from Visit 10 (Day 36±1 day) to Visit 14 (end of treatment; Day 85±2 days).
    Pharmacokinetics (PK):
     Plasma concentrations of goserelin.
    Safety:
     Occurrence of serious and non-serious adverse events (AEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be drawn at Visits 2 (Day 1), Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8±1 day), Visit 6 (Day 15±2 days), Visit 7 (Day 29±1 day), Visit 8 (Day 30), Visit 9 (Day 32), Visit 10 (Day 36±1 day), Visit 11 (Day 43±2 days), Visit 12 (Day 57±1 day), Visit 13 (Day 71±2 days), Visit 14 (Day 85±2 days) and Visit 15 (as soon as possible after return of the patient’s menses or at the latest at Day 141±3 days) for oestradiol, LH, FSH and goserelin levels.
    Blood samples for biochemistry and haematology testing and a urine sample for urinalysis
    will be collected at Visit 1 (Screening; Day -28 to Day -4) and Visit 15 (as soon as possible after return of the patient’s menses or at the latest at Day 141±3 days) for safety purposes.
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA19
    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
    LAST PATIENT-LAST VISIT
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days24
    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: 142
    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 No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 142
    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 Decision2016-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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