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    Summary
    EudraCT Number:2011-005167-24
    Sponsor's Protocol Code Number:PGL11-007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-005167-24
    A.3Full title of the trial
    A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo controlled Study of the Steroid Sulfatase Inhibitor PGL2001 with concomitant administration of NETA (norethisterone acetate) for the treatment of symptoms related to endometriosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine the efficacy and safety of PGL2001 for the symptoms related to endometriosis, when taken with norethisterone acetate
    A.3.2Name or abbreviated title of the trial where available
    AMBER
    A.4.1Sponsor's protocol code numberPGL11-007
    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 organisationTheorem Clinical Research GmbH
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressKönigsteiner Str. 10
    B.5.3.2Town/ cityBad Soden a. Ts.
    B.5.3.3Post code65812
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)2234 1852 0
    B.5.5Fax number+49(0)6196 5228155
    B.5.6E-mailUlrike.Kritzler@theroremclinical.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 nameEstradiol sulfamate
    D.3.2Product code PGL2001
    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.3.9.1CAS number 172377-52-5
    D.3.9.2Current sponsor codePGL2001
    D.3.9.3Other descriptive nameJ995, ZK190628, Estradiol Sulfamate, E2MATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of symptoms related to endometriosis
    E.1.1.1Medical condition in easily understood language
    Symptomatic 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 16.0
    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 evaluate the efficacy of PGL2001 with concomitant, continuous NETA administration versus placebo with concomitant, continuous NETA administration to relieve pain symptoms associated with endometriosis by Week 16 (end of PGL2001 treatment)
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of PGL2001 with concomitant, continuous NETA administration to relieve pain symptoms associated with endometriosis over 28 weeks after end of treatment with PGL2001 (Week 16 up to Week 44).
    •To evaluate the safety and tolerability of PGL2001 with concomitant, continuous NETA administration during 16-week PGL2001 treatment period and up to Week44 (28 weeks follow-up period).
    •To evaluate the efficacy of PGL2001 with concomitant, continuous NETA administration to improve symptoms associated with endometriosis by Week 16 (end of PGL2001 treatment) and up to Week 44 (28 weeks follow-up period).
    •To evaluate the pharmacokinetics (PK trough levels) of PGL2001 with concomitant, continuous NETA administration during 16 week PGL2001 treatment period and up to Week 44 (28 weeks follow-up period).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must:
    1.Provide written informed consent prior to initiation of any study related procedures.
    2.Be a woman of reproductive age between 18 and 45 years inclusive at screening.
    3.Have a FSH < 30 mlU/ml (taken at Day 2-4 of menstrual cycle).
    4.Have a BMI of 18 – 30 kg/m2 (inclusive).
    5.Have a score of ≥ 40 on the pain index of the EHP-30
    6.Have a history of regular menstrual cycles (22-36 days) while not being on oral contraceptive pills (at least 6 months since stopping of OC).
    7.Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.
    8.Present with clinical signs suggestive of endometriosis (e.g. painful gynaecological exam, palpable endometriotic lesions, radiologic or ultrasound suspicion of endometriosis).
    9.Be able and willing to comply with the requirements of the protocol.
    10.Must use a barrier method or abstinence if sexually active with a male partner for the first 7 days of treatment if NETA administration was not done on day 1 of the menstrual cycle.
    E.4Principal exclusion criteria
    Subjects must not:
    1.Be pregnant or currently lactating.
    2.Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
    3.Have had any surgical treatment for endometriosis within the last 12 months
    4.Have documented significant adenomyosis.
    5.Have a history of or a current uterus, cervix, ovarian or breast cancer.
    6.Have a history of atypical endometrial hyperplasia which has not been diagnosed as reversed to benign endometrium.
    7.Have a significant finding on Papanikolaou test (PAP) smear within the past 12 months.
    8.Desire to conceive within the course of the study.
    9.Have significant adnexal abnormalities other than endometriosis.
    10.Have any chronic disease (e.g. hepatic or renal impairment) or conditions that could modify the absorption, distribution, metabolism, or excretion of the drugs under investigation.
    11.Suffering from chronic pain and requiring or be likely to require any pain medication (NSAIDs and Non-NSAIDs) during the study
    12.Take or have taken any hormonal treatment within the last 6 months
    13.Take or have taken at any time therapies for endometriosis other than NSAID’s (e.g. GnRH agonist or antagonist, OC pills continuously (28 day regimen) or danazol).
    14.Be likely to require treatment with drugs that are not permitted during the study such as:
    a.Drugs interacting with CYP3A4 metabolism (inhibition or induction, listed in Appendix C) or carbonic anhydrase inhibition (see section 6.6.2).
    b.Hormonal contraceptives including progestin releasing devices.
    c.GnRH-Agonists/ Antagonists
    d.Danazol
    e.Tranexamic acid
    15.Have abnormal hepatic function at study entry, defined as AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single retest is allowed
    16.Have contraindications to progestins such as:
    a.thromboembolic disorders,
    b.arterial and cardiovascular disease,
    c.diabetes mellitus with vascular involvement,
    d.liver tumour,
    e.Dubin-Johnson or Rotor syndrome.
    17.Have contraindication or intolerance to NSAIDs.
    18.Have any clinically relevant allergy or drug hypersensitivity.
    19.Be at risk of haemolysis:
    a.Subjects having a known sickle cell disease or a known G6PD deficiency.
    b.Subjects likely to need medication causing haemolysis (e.g. dapsone, sulfasalazine, primaquine, etc.) during the course of the study.
    20.Have abnormal baseline findings or any other medical condition(s), which in the opinion of the investigator, may jeopardise the subject’s safety or decrease the chance of obtaining reliable data.
    21.Positive serology for HIV, Hepatitis B and C
    22.Have a history of, or known current problems with alcohol or drug abuse.
    23.Have psychiatric disturbance or be otherwise unlikely to follow the study procedures.
    24.Have participated in another clinical trial within the 30 days prior to the screening visit
    E.5 End points
    E.5.1Primary end point(s)
    •Change from baseline to end of double-blind PGL2001/Placebo treatment in non-menstrual pelvic pain as reported using a Visual Analogue Scale (VAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After week 16
    E.5.2Secondary end point(s)
    •Efficacy up to end of the double-blind PGL2001/Placebo treatment period (including PD and PGL2001/PGL2002 Cmin assessments)
    •Efficacy up to end of follow-up period (including PD and PGL 2001/PGL2002 Cmin assessments)
    •Safety during the double-blind PGL2001/Placebo treatment and follow-up period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After week 16 and at the end of 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock.
    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 months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    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: 132
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 132
    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)
    Not applicable. Please refer to the standard endometriosis treatment available on the market.
    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 Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-28
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