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    Summary
    EudraCT Number:2014-004409-34
    Sponsor's Protocol Code Number:ESN364-PCO-201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-25
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004409-34
    A.3Full title of the trial
    Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndromential.
    A.4.1Sponsor's protocol code numberESN364-PCO-201
    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 SponsorEuroscreen 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 supportEuroscreen S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuroscreen S.A
    B.5.2Functional name of contact pointSteven Ramael
    B.5.3 Address:
    B.5.3.1Street Address 47 Rue Adrienne Bolland
    B.5.3.2Town/ cityGosselies
    B.5.3.3Post code6047
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 71 348 500
    B.5.5Fax number+32 71 348 519
    B.5.6E-mailsramael@euroscreen.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 nameESN-364
    D.3.2Product code ESN-364
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnot assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeESN-364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.IMP: 2
    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 nameESN-364
    D.3.2Product code ESN-364
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnot assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeESN-364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 placeboCapsule, hard
    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
    Polycystic Ovarian Syndrome
    E.1.1.1Medical condition in easily understood language
    hormone related disorder
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10065161
    E.1.2Term Polycystic ovarian syndrome
    E.1.2System Organ Class 100000004872
    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 efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levels.
    E.2.2Secondary objectives of the trial
    • To evaluate effect of two doses of ESN364 versus placebo to decrease luteinizing hormone (LH), free and total testosterone (TT) at Week 6, Week 12 (end-of-treatment), and Week 18
    • To evaluate effect of two doses of ESN364 versus placebo to change progesterone (P4) and estradiol levels (E2) at Week 6, Week 12 (end-of-treatment), and Week 18
    • To evaluate effect of two doses of ESN364 versus placebo to change follicle stimulating hormone (FSH) levels and LH/FSH ratio at Week 6, Week 12 (end-of-treatment), and Week 18
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Pre-menopausal woman between 18 and 45 years inclusive at screening;
    2) Diagnosed with PCOS according to the Rotterdam criteria with the following modification: biochemical hyperandrogenism is mandatory (TT >50 ng/dL [1.735 nmol/L] at screening and at least one of the following two other Rotterdam criteria are additionally required for diagnosis of PCOS:
    • Oligomenorrhea (≤6 menses per year) or oligo-ovulation and/or
    • Polycystic ovaries on ultrasound (≥12 antral follicles in at least one ovary or ovarian volume ≥10 cm3);
    3) Normal thyroid function (thyroid stimulating hormone [TSH] compatible with normal thyroid function); Mild hypothyroidy treated with stable hormone replacement therapy is allowed if TSH is normal;
    4) FSH and E2 within normal limits as judged by the investigator
    5) Normal prolactin (PRL) levels;
    6) Normal 17-hydroxy-progesterone levels (<200 ng/dL, compatible with normal 21-hydroxylase activity);
    7) In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening; hematology and chemistry parameters, heart rate (HR) and/or blood pressure, and electrocardiogram (ECG) within the reference range for the population studies, or showing no clinically relevant deviations, as judged by the investigator;
    8) Has a negative (normal or atypical squamous cell of uncertain significance) cervical smear (Papanikolaou test [PAP], cytobrush or equivalent) within 36 months prior to screening;
    9) Negative urine test for selected drugs (amphetamines benzodiazepines, cannabinoids, cocaine, tetrahydrocannabinol, barbiturates or opiates) of abuse at screening and before first administration of study drug;
    10) Negative pregnancy test at screening and before randomization; not have been pregnant within 6 months prior to screening;
    Note: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other visits.
    11) Women of childbearing potential agrees not to get pregnant and willing to be abstinent or to use adequate highly effective contraception (failure rate less than 1% per year) during the trial and for at least 42 days after end of treatment;
    The following non-hormonal contraceptive methods are defined as acceptable:
    • Partner with a vasectomy performed at least 3 months prior to the study and with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. (The vasectomized male partner should be the sole partner for that subject).
    • True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptom-thermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
    • Hormone-free intrauterine device (copper intrauterine device) in combination with a condom
    • The subject is homosexual/has no intercourse with the opposite sex
    • Partner is using condoms in combination with spermicidal cream or gel
    Women of childbearing potential are defined as any female who has experienced menarche and are not post-menopausal or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy);
    12) Willing to adhere to the prohibitions and restrictions specified in the protocol;
    13) Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed; indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
    E.4Principal exclusion criteria
    1) Evidence of diabetes diagnosed on any of the following World Health Organization (WHO) criteria:
    - Fasting plasma glucose (FPG) ≥7.0 mmol/l (126 mg/dl) or,
    - Glycated hemoglobin (HbA1c) ≥6.5% /48 mmol/mol or,
    - Random plasma glucose ≥11.1 mmol/l (200 mg/dl) in the presence of classical diabetes symptoms;
    2) Concomitant use of insulin sensitizers is not allowed, if taken, they should be stopped at screening;
    3) Use of anti-androgens within 3 months prior to screening;
    4) Have been treated within 3 months of screening with any of the following drugs: GnRH agonist/antagonist, selective estrogen receptor modulator (SERM), selective progesterone receptor modulator (SPRM), dienogest, danazol aromatase inhibitor, glucocorticoids, mineralocorticoids, androgens, and depot contraceptive preparations;
    5) Treatment with hormonal contraceptives (oral, transdermal, coated intrauterine device) should be stopped 1 month prior to screening;
    6) Has undergone bariatric surgery within 6 months prior to screening;
    7) Has undergone ovarian surgery (drilling, wedge resection,…) within 6 months prior to screening;
    8) Has undergone hysterectomy or bilateral oophorectomy or both;
    9) Has Cushing’s syndrome;
    10) Has a history of or currently ongoing pelvic inflammatory disease;
    11) Has a known severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients;
    12) Has a history of or a currently ongoing malignant tumor (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence);
    13) Has active liver disease or jaundice, or with out-of-range values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST); or total bilirubin >1.3 times the upper limit of normal (ULN); or creatinine >1.25 times the ULN at screening;
    14) Has any psychological disorder according to criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders, 4th edition within one year before screening. Such disorders include, but are not limited to, alcohol (more than 3 glasses of wine, beer, or equivalent/day) and substance abuse/dependence within 2 years prior to the initial study medication administration;
    15) Hemoglobin level <10 g/dL;
    16) Has symptoms of clinically relevant acute or chronic illness in the 3 months before the initial study administration;
    17) Judged by investigator to be inappropriate to participate in this study based on findings on the ECG regarding rhythm or conduction. A first degree AV block will not be considered as a significant abnormality;
    18) Had a significant blood loss (including blood donation [>500 mL]) or had a transfusion of any blood product within 12 weeks prior to the initial study medication administration;
    19) Has a medical condition or chronic disease (including neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcome as judged by the investigator;
    20) Has a history of poor compliance in clinical research studies;
    21) Concurrent participation or participation within 3 months prior to screening in a drug/device or biologic investigational research study;
    22) Subject is the investigator oor any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study;
    23) Has a positive hepatitis panel (including hepatitis B surface antigen [HBsAg] or anti-hepatitis C virus [HCV] antibodies) or positive human immunodeficiency virus (HIV) antibody at screening;
    24) Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Change in TT levels from baseline to end-of-treatment Visit (Week 12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the trial
    E.5.2Secondary end point(s)
    • Changes in menstrual cycle as measured by frequency menses, spotting, inter-menstrual bleedings
    • Change from baseline in the PCOSQ score (total and subcategories) at Week 6 and Week 12 (end-of-treatment)
    • Change in sex hormone levels (LH, free and TT levels) from baseline to Week 6, Week 12 (end-of-treatment), and Week 18 (Follow-up)
    • Change in sex hormone levels (P4, and E2 levels) from baseline to Week 6, Week 12 (end-of-treatment), and Week 18 (Follow-up)
    • Change in sex hormone levels (FSH and LH/FSH ratio) from baseline to Week 6, Week 12 (end-of-treatment), and Week 18 (Follow-up)
    • Change in TT levels from baseline to Week 9 (at trough PK levels)
    • Change in endometrium thickness, ovarian volume, number of follicles (cysts), and dominant follicle development (Y/N) assessed by 2D transvaginal ultrasound from baseline to Week 6 and Week 12 (end-of-treatment)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during 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 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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 24
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    see protocol
    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 Decision2015-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-01
    P. End of Trial
    P.End of Trial StatusCompleted
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