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    Summary
    EudraCT Number:2020-004302-63
    Sponsor's Protocol Code Number:CLI20001/Lita005
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-09
    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 number2020-004302-63
    A.3Full title of the trial
    A multi-centre, open-label, single-arm study assessing the safety and efficacy of 5 mg of mifepristone for the treatment of endometriosis in reproductive-age women during two treatment cycles of 24 weeks each
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-centre, open-label, single-arm study assessing the safety and efficacy of 5 mg of mifepristone for the treatment of endometriosis in reproductive-age women during two treatment cycles of 24 weeks each
    A.3.2Name or abbreviated title of the trial where available
    Multi-centre, open-label study assessing the safety and efficacy of 5 mg of mifepristone in patients
    A.4.1Sponsor's protocol code numberCLI20001/Lita005
    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 SponsorLitaphar Laboratorios S.L.
    B.1.3.4CountrySpain
    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 supportLitaphar Laboratorios S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLitaphar Laboratorios S.L.
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressLoiolabide 7, bajo
    B.5.3.2Town/ cityAzpeitia (Gipuzkoa)
    B.5.3.3Post code20730
    B.5.3.4CountrySpain
    B.5.4Telephone number34943157299
    B.5.6E-mailgtomasi@litaphar.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 nameMifepristone 5 mg
    D.3.2Product code Mifepristone 5 mg
    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 INNMIFEPRISTONE
    D.3.9.1CAS number 84371-65-3
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB08956MIG
    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.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 in reproductive-age
    E.1.1.1Medical condition in easily understood language
    endometriosis in reproductive-age
    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 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
    Assessment of safety of 5 mg of mifepristone for the treatment of endometriosis in premenopausal women during two treatment cycles of 24 weeks each based on the incidence of endometrial abnormalities, defined as cancer or endometrial hyperplasia, as measured by endometrial biopsy.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the present trial are the assessment of the following safety outcomes after treatment with Mifepristone 5 mg over two 24-week treatment cycles:
    • change in endometrial thickness as measured by transvaginal ultrasound
    • safety of mifepristone for the treatment of endometriosis in terms of the incidence of Adverse Events and Serious Adverse Events
    • vaginal bleeding during treatment with mifepristone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Premenopausal female, from 18 years of age inclusive, at the time of signing consent
    [2] Patients with Endometriosis Associated Pelvic Pain (EAPP: i.e. any type of pelvic pain associated with endometriosis: non-menstrual pelvic pain, dysmenorrhea, dyschezia and dyspareunia) and with history of EAPP for at least the past 6 months prior to the initial screening visit
    [3] Endometriosis diagnosed by laparoscopy and/or surgery in the past 10 years or less or diagnosed by MRI or transvaginal ultrasound in the past 5 years
    [4] Patients with a history of regular menstrual cycles (21-35 days) while not being on any pharmacological treatment that could alter the menstrual cycle (e.g. oral contraceptive pills)
    [5] Patients who agree to use only ibuprofen 400 mg as rescue medication up to a total daily dose of not more than 2400 mg
    [6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent
    [7] Patient agrees to use double barrier contraception birth control methods (e.g. condom with spermicide) during the entire length of participation in the study. Patient is not required to use double barrier contraception methods if:
    - Sexual partner(s) is (are) vasectomized, at least 6 months prior to screening
    - Patient has had a bilateral tubal occlusion (including ligation and blockage methods such as Essure®), at least 3 months prior to screening
    - Patient is not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above.
    E.4Principal exclusion criteria
    [1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study medication
    [2] Subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the study or is less than 6 months postpartum, post-abortion, or post-lactation at the time of entry into the screening period
    [3] Previous use of hormonal agents before the Screening visit: ≤24 weeks for GnRH agonists; ≤12 weeks for depot progestogens and danazol: ≤6 weeks for oral contraceptives
    [4] Use of intrauterine device
    [5] Patients with history of any cancer (including breast cancer)
    [6] Patients with histological diagnosis of endometrial hyperplasia with or without atypia at screening (note: the combination of endometrial thickness <5 mm determined by transvaginal ultrasound and insufficient material for histological evaluation from the endometrial biopsy will be regarded as atrophic endometrium)
    [7] Other clinically significant gynaecological condition causing abnormal uterine bleeding already known or identified on Screening such as severe adenomyosis or symptomatic uterine fibroids requiring treatment
    [8] Subject has current or history of abnormal genital bleeding
    [9] Presence of ovarian cyst of unknown etiology
    [10] Cervical smear with pathological findings: class III or higher according to Papanicolaou, class IIp or higher according to the Munich III nomenclature or ASC-US or higher according to the Bethesda system
    [11] Surgical treatment of endometriosis within 3 months prior to the screening visit
    [12] Presence of chronic pain other than pain due to endometriosis
    [13] Hepatic insufficiency
    [14] History of, or complications of, thrombosis, embolism, or serious cardiac, respiratory (severe asthma not adequately controlled by treatment), renal, hematologic, endocrine diseases
    [15] Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure > 180 mmHg or > 95 mmHg, respectively
    [16] Subject with hereditary porphyria
    [17] Abnormal laboratory findings considered by the investigator as clinically significant
    [18] Positive results for HBs-Ag, anti-HCV and HIV-1/HIV-2-antibodies
    [19] Use of drugs that could be expected to affect the release of sex hormones (e.g., antipsychotics); hypericum and CYP3A4 inductors (carbamazepine, phenobarbital, phenytoin, primidone, rifampicin) or inhibitors (such as cyclosporine, macrolide antibiotics, nefazodone, azolic antifungal agents and HIV protease inhibitors)
    [20] Intake of any analgesics other than ibuprofen: both opioids and non-steroidal anti-inflammatory drugs as well as paracetamol or metamizole during the screening period
    [21] History of drug or alcohol abuse within 6 months prior to screening
    [22] Participation in another trial within 3 months from the screening visit date;
    [23] Previous enrolment in this study or randomisation in study EudraCT 2018-002367-26/Lita-003
    [24] Any condition that, in the judgment of the investigator, may interfere with adherence to study procedures or study assessments
    [25] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
    [26] Unreliability or lack of cooperation.
    E.5 End points
    E.5.1Primary end point(s)
    Histological appearance of the endometrium at Week 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle and Follow-up visit as well as optional at Week 12 of the 1st treatment cycle and at Week 0 of the 2nd treatment cycle. The overall outcome analysed will be binary:
    • Cancer or endometrial hyperplasia
    • All other assessments, including PAECs
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle
    E.5.2Secondary end point(s)
    • Changes from baseline in endometrial thickness at Weeks 12 and 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle.
    • Evaluation of vaginal bleeding throughout the trial
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Changes from baseline in endometrial thickness at Weeks 12 and 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle.
    • Evaluation of vaginal bleeding throughout the trial
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hungary
    Poland
    Ukraine
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 300
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 300
    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
    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 Decision2020-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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