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    Summary
    EudraCT Number:2013-005494-53
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-09-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-005494-53
    A.3Full title of the trial
    A Study of the Histopathological Changes within Ectopic Endometrial Tissue, in Subjects with Known Pelvic Endometriosis Following Treatment with Ulipristal Acetate, a Selective Progesterone Receptor Modulator (SPRM).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Histological Changes within Ectopic Endometrial Tissue, in Subjects with Pelvic Endometriosis- Following Treatment with Ulipristal Acetate, a Selective Progesterone Receptor Modulator (SPRM).
    A.3.2Name or abbreviated title of the trial where available
    Changes in Histology following Ulipristal Therapy in Endometriosis 1.1
    A.4.1Sponsor's protocol code number
    A.5.4Other Identifiers
    Name:R&D reference numberNumber:2013O&G04C (53-04-13)
    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 SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportPregLem SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorfolk and Norwich University Hospital NHS trust
    B.5.2Functional name of contact pointEdward Morris
    B.5.3 Address:
    B.5.3.1Street AddressColney lane
    B.5.3.2Town/ cityNorwich
    B.5.3.3Post codeNR47UY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01603 286829
    B.5.5Fax number01603 287532
    B.5.6E-mailedward.morris@nnuh.nhs.uk
    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 Plc.
    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 nameUlipristal Acetate (Esmya)
    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 INNUlipristal (INN) Acetate
    D.3.9.1CAS number 126784-99-4
    D.3.9.2Current sponsor codePGL4001
    D.3.9.3Other descriptive nameEsmya
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    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
    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 PT
    E.1.2Classification code 10057902
    E.1.2Term Endometriosis ablation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014785
    E.1.2Term Endometriosis of pelvic peritoneum
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014788
    E.1.2Term Endometriosis related pain
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014779
    E.1.2Term Endometriosis in pelvis, excision
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 describe the post-treatment histological appearance in ectopic endometrial deposits found in patients with pelvic endometriosis after a course of Ulipristal acetate.
    E.2.2Secondary objectives of the trial
    To study the change in disease severity (symptomatic and laparoscopic appearance) following treatment with Ulipristal acetate.

    To correlate any symptom changes with the post treatment histological changes in the ectopic endometrium.

    To assess the histological changes in the eutopic endometrium following treatment with Ulipristal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study related procedures.
    2. Pre-menopausal women between 18 and 50 years inclusive.
    3. Subject with a Body Mass Index ≥18 and ≤40.
    4. Regular menstrual pattern with cycle length 22-35 days.
    5. Surgically (laparoscopic) diagnosed endometriosis requiring further surgical treatment.
    6. If sexually active, agrees to use of adequate non-hormonal contraceptive method(s) to prevent pregnancy for duration of study and 12 weeks after the last dose:
    a. subject has undergone surgical sterilisation
    b. subjects partner has undergone surgical sterilisation (>12 weeks before consent signed)
    c. condoms
    d. non-hormonal intra-uterine device
    e. abstinence
    7. No abnormality on screening breast examination.
    8. Subject is willing to take part in study and understands definitive surgery will be delayed until course of Ulipristal acetate is completed.
    E.4Principal exclusion criteria
    1. The subject has a history of or current uterus, cervix, ovarian or breast cancer.
    2. The subject has had a significant and persisting finding on cervical screening (liquid based cytology)smear within the past 12 months.
    3. The subject has a history of endometrial hyperplasia or abnormalities detected on first endometrial biopsy.
    4. Subject has one or more endometrioma ≥ 4cm diagnosed during diagnositic laparoscopy.
    5. The subject has a history of treatment for leiomyoma with a SPRM.
    6. The subject has been taking prohibited medication:
    o Treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within the month before the screening visit.
    o Acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexemic acid within one week before the screening visit
    o Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively.
    o GnRH agonist and antagonist:
     Immediate or monthly sustained release depot preparation or immediate release form within 6 months of screening visit
     3 or 6 months sustained release depot preparation within 12 months before the screening visit.
    7. The subject is likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), hormonal contraceptives, systemic glucocorticoids (oral and injectable), GnRH agonist and GnRH antagonists.
    8. The subject requires treatment with a medication which includes potent inhibitors of CYP3A4 (such as ketoconazole)
    9. The subject requires treatment with a medication which includes potent inducers of CYP3A4 (such as rifampicin).
    10. The subject has abnormal hepatic function at study entry (defined as alanine transaminase [ALT], hepatic alkaline phosphatase, or total bilirubin above twice the upper limit of normal). In case of isolated elevated GGT, the subject may be enrolled if the re-test is within the allowed limits.
    11. The subject has a positive pregnancy test at baseline, is nursing or planning a pregnancy during the course of the study.
    12. The subject has a problem with alcohol or drug abuse.
    13. The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    14. The subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject‟s safety or interfere with study evaluations.
    15. The subject has an allergy to SPRMs or progestins or any of the ingredients of the study drug tablet (Microcrystalline cellulose, Mannitol, Croscarmellose sodium, Talc, Magnesium Stearate (vegetable origin)).
    16. The subject is currently enrolled in an investigational drug or device study or participated in such a study within the previous 30 days and is still in exclusion period.
    E.5 End points
    E.5.1Primary end point(s)
    As this is an interventional descriptive cohort study the primary outcome data will be qualitative and descriptive. We aim to describe the post-treatment histological appearance in ectopic endometrial deposits found in patients with pelvic endometriosis after a 3 month course of Ulipristal acetate.

    The histological data for each subject will be described and grouped according to any features found. The data will be presented as text/tables/figures throughout the written text of the study report.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This evaluation will take place at the end of the 3 month treatment course.
    E.5.2Secondary end point(s)
    Changes in disease severity will be assessed by comparing the laparoscopic appearance of endometriotic lesions between the diagnostic surgery and the second definitive surgery. These changes will be correlated with any quantitative changes identified in the patient reported outcome questionnaires:

    • Change from baseline to the End of Treatment (EoT) of the average scores of the Composite Pelvic Signs & Symptoms Score (CPSSS).
    • Change from baseline to the End of Treatment (EoT) of the average scores of the Endometriosis Health Profile Questionnaire (EHP-30).
    • Change from baseline to the End of Study of the average scores of the BSGE Pelvic Pain Questionnaire
    • The average results of the Patients’ Global Impression of Change (PGIC) scale will be reported as a direct measure of patient satisfaction.

    Changes in the disease severity (patient reported outcomes and laparoscopic appearance) will be correlated with the histology of the ectopic endometrium, if relevant. Any associations will be described and highlighted.

    The histological appearance and receptor expression of the eutopic endometrium will be described for both pre- and post treatment. The post treatment samples will be analysed separately before undertaking any comparison between pre- and post- treatment samples. In particular, any features consistent with PAEC (progesterone receptor modulator associated endometrial changes) will be highlighted to inform any post-op follow up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This evaluation will take place at the end of the 3 month treatment course.
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state20
    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 study drug will not be available to the participants after the end of the study protocol though it is anticipated that the need for further drug will be low following the planned surgery to treat endometriosis.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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