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    Summary
    EudraCT Number:2012-001465-33
    Sponsor's Protocol Code Number:PGL11-024
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-001465-33
    A.3Full title of the trial
    A Phase III, multicentre, extension study investigating the
    efficacy and safety of repeated intermittent 3-month courses
    of open-label administration of ulipristal acetate, in subjects
    with symptomatic uterine myomas and heavy uterine
    bleeding.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PGL4001 Efficacy Assessment in Reduction of symptoms due
    to uterine Leiomyomata
    A.3.2Name or abbreviated title of the trial where available
    PEARL extension 2
    A.4.1Sponsor's protocol code numberPGL11-024
    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 SponsorPregLem S.A.
    B.1.3.4CountrySwitzerland
    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 S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPregLem S.A.
    B.5.2Functional name of contact pointGeneral Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressChemin du Pré-Fleuri 3,
    B.5.3.2Town/ cityPlan-Les-Ouates, Geneva
    B.5.3.3Post code 1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 (0)22 884 0340
    B.5.5Fax number +41 (0)22884 0349
    B.5.6E-mailinfo@preglem.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 nameulipristal acetate
    D.3.2Product code PGL4001
    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 acetate
    D.3.9.1CAS number 126784-99-4
    D.3.9.2Current sponsor codePGL4001
    D.3.9.3Other descriptive nameVA2914 (HRA), CDB-2914 (NICHD), RTI 3021-012 (RTI), HRP-2000 (World Health Organization (WHO))
    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 number10
    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
    Uterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus.
    They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility.
    E.1.1.1Medical condition in easily understood language
    Uterine fibroid
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10046801
    E.1.2Term Uterine myoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 treatment satisfaction of patients receiving repeated intermittent ulipristal acetate treatment courses using a Global Study Treatment Satisfaction Questionnaire
    E.2.2Secondary objectives of the trial
    - To assess the treatment satisfaction of pts receiving repeated intermittent ulipristal acetate courses using a Global Study Treatment Satisfaction Questionnaire (at additional time points)
    - To assess QoL (measured with EQ-5D and UFS-QoL questionnaires) and pain (using VAS)
    - To assess the sustained efficacy of repeated intermittent 3-month courses of daily adm of ulipristal acetate on myoma size
    - To assess uterine bleeding characteristics (using PBAC) at re-start of treatment at the beginning of the study in patients who have already completed 4 previous courses of ulipristal acetate
    - To assess the long-term safety of repeated intermittent 3-month administration of ulipristal acetate, specifically with regards to the endometrium and the occurrence of adverse events
    - To assess the incidence of PAEC, 10-18 days after the 1st menstruation following the last course with ulipristal acetate
    - To asses the incidence and type of surgery for uterine myomas during the study period
    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. Subject completed visit F – Follow-up of Pearl III extension study (PGL09-027) - without significant deviations.
    3. Subject has no contra-indication to enter the long term extension study, based on the investigator’s judgment.
    4. Females of childbearing potential are advised to practice a non-hormonal method of contraception among one of the following:
    a. Sexual abstinence
    b. Diaphragms
    c. Condom or having a partner with a vasectomy with either confirmed azoospermia or performed at least 6 months prior to the study.
    E.4Principal exclusion criteria
    1. Subject has a history of uterus surgery (e.g. hysterectomy, myomectomy) or uterine artery embolization in Pearl III extension (PGL09-027) or afterwards that would interfere with the study assessments.
    2. Subject has taken or 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), oestrogens, GnRH-Agonists/Antagonists, hormonal contraceptives, systemic glucocorticoids (oral and injectable), and/or treatments with potent inhibitors or inducers of CYP3A4. Wash-out periods prior to Visit I are as follows:
    a. Progestins and Oestrogens: 1 month
    b. GnRH-Agonists/Antagonists: 3 months
    c. Systemic glucocorticoids: 1 month (3 months after depot injections)
    d. CYP3A4 inhibitors or inducers: 2 weeks
    3. Subject is lactating, has a positive pregnancy test at study start or is planning a pregnancy during the course of the study.
    4. Subject has a current problem with alcohol or drug abuse.
    5. 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.
    6. Subject has abnormal baseline findings, any other medical condition(s) or laboratory finding that, in the opinion of the investigator, might jeopardise the subject’s safety or interfere with study evaluations.
    E.5 End points
    E.5.1Primary end point(s)
    - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit II (Average score of the first 3 questions)
    - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit III (Average Score of the first 3 questions).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At visit II and visit III
    E.5.2Secondary end point(s)
    Efficacy:
    - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit I (Average score of the first 3 questions).
    - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visit IV (Average score of the first 3 questions).
    - Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire at visits I, II, III and IV (Individual component scores).
    - Change from visit 2 of Pearl III (PGL09-026) and visit F of Pearl III extension (PGL09-027) to visits II, III and IV in quality of life (using EQ-5D and UFS-QoL questionnaires) and in pain (using VAS).
    - Change from visit 1 of Pearl III (PGL09-026) and visit F of Pearl III extension (PGL09-027) to visits II, III and IV in myoma size, measured on the three largest myomas identified at visit 1 of PGL09-026, by transvaginal ultrasound.
    - Change from the first menstruation at the start of Pearl III (PGL09-026) study to the first menstrual bleeding at re-start of the first ulipristal acetate treatment course (in PGL11-024) in strength of the bleeding, using the Pictorial Bleeding Assessment Chart (PBAC).
    Safety:
    - Number and proportion of subjects experiencing treatment-emergent adverse events including patient-reported adverse events and clinically significant changes in the parameters listed below:
    o Laboratory parameters (haematology, chemistry, lipids).
    Change from visit F of Pearl III extension (PGL09-027) to visits II, III and IV in
    endometrial thickness assessed by transvaginal ultrasound.
    o Visit III endometrium biopsy (i.e. hyperplasia, adenocarcinoma).
    Exploratory:
    - Frequency of PAEC observed in the endometrial biopsy, on day 10-18 after the first menstruation following the last treatment course with ulipristal acetate.
    - Proportion of subjects having surgery or any invasive procedure for myoma treatment at any time during the study (type of surgery/ procedure performed).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: At visits I, II, III and IV
    Safety: At visists II, III and IV
    Exploratory: At any time during the study
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Final clinical database lock
    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 months8
    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 months8
    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: 90
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    Subjects, who discontinue after at least 4 weeks of treatment with ulipristal acetate, will be asked to undergo the same assessments as those planned during visit IV, plus an endometrium biopsy. Subjects, who discontinue prior to 4 weeks of treatment with ulipristal acetate, will be asked to attend a follow-up visit, which will include the same assessments as visit IV, without an endometrium biopsy. No extension studies are planned.
    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 Decision2012-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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