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    Summary
    EudraCT Number:2016-002092-10
    Sponsor's Protocol Code Number:EVE112-CT03-2016
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-19
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-002092-10
    A.3Full title of the trial
    Comparative reference-controlled investigation of bleeding pattern under treatment with a vaginal delivery system (EVE112) containing a fixed dose combination of etonogestrel and ethinylestradiol – A multi-centre, multi-dose, open-label, parallel-group study in healthy females aged 18-40 years and at risk for becoming pregnant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative reference-controlled investigation of bleeding pattern under treatment with a vaginal delivery system (EVE112) containing a fixed dose combination of etonogestrel and ethinylestradiol – A multi-centre, multi-dose, open-label, parallel-group study in healthy females aged 18-40 years and at risk for becoming pregnant
    A.3.2Name or abbreviated title of the trial where available
    Investigation of bleeding pattern with vaginal delivery systems in healthy females
    A.4.1Sponsor's protocol code numberEVE112-CT03-2016
    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 SponsorEvestra GmbH
    B.1.3.4CountryGermany
    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 supportSocraTec GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSocraTec GmbH
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressIm Setzling 35
    B.5.3.2Town/ cityOberursel
    B.5.3.3Post code61440
    B.5.3.4CountryGermany
    B.5.4Telephone number4906171585710
    B.5.5Fax number49061715857125
    B.5.6E-mailmaria.anschuetz@socratec-pharma.de
    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 nameEVE112
    D.3.4Pharmaceutical form Vaginal delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETHINYLESTRADIOL
    D.3.9.2Current sponsor codeEE
    D.3.9.4EV Substance CodeSUB07277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.85
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETONOGESTREL
    D.3.9.2Current sponsor codeENG
    D.3.9.4EV Substance CodeSUB07335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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 RoleComparator
    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 NuvaRing
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Oragnon (Netherlands)
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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.3.4Pharmaceutical form Vaginal delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETHINYLESTRADIOL
    D.3.9.2Current sponsor codeEE
    D.3.9.4EV Substance CodeSUB07277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETONOGESTREL
    D.3.9.2Current sponsor codeENG
    D.3.9.4EV Substance CodeSUB07335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.7
    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
    Safety, efficacy and tolerability investigations of a hormonal contraceptive in healthy females aged 18-40 years.
    E.1.1.1Medical condition in easily understood language
    Safety, efficacy and tolerability investigations of a hormonal contraceptive in healthy females aged 18-40 years.
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10073728
    E.1.2Term Hormonal contraception
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - descriptive comparison of the effect of Test and Reference on bleeding pattern over 6 cycles of treatment
    - assessment of pregnancy rates under treatment with Test and Reference over 6 cycles of treatment
    - descriptive comparison of the effect of Test and Reference on haemostasis parameters over 6 cycles of treatment
    - descriptive characterisation of the safety (including local tolerability) of Test and Reference over 6 cycles of treatment
    E.2.2Secondary objectives of the trial
    - descriptive characterisation of the safety (including local tolerability) of Test and Reference over a total of 13 cycles of treatment (including 7 cycles of safety follow-up)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. sexually active, at risk for becoming pregnant and in a mutually monogamous relationship for at least 6 months at study entry
    2. willing to rely on the IMPs as the primary method of contraception during study participation
    3. age: ≥ 18 years and ≤ 40 years
    4. body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 32.0 kg/m²
    5. good state of health
    6. non-smoker, ex-smoker or moderate smoker (<10 cigarettes per day) for at least 3 months
    7. known regular menstrual cycles from 21 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range for at least 6 months
    8. signed and dated informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
    E.4Principal exclusion criteria
    1. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
    2. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
    3. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
    4. known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
    5. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
    6. presence of clinical relevant hypertension judged by investigator
    7. laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
    8. having a partner who is known to be HIV-positive
    9. presence or history of venous or arterial thrombosis (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction or prodromal conditions (e.g. angina pectoris, transient ischaemic attack)), cerebrovascular accident, inborn or acquired predisposition for venous or arterial thrombosis such as APC resistance, antithrombin-III-deficiency, protein-C or –S-deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant, known Leiden factor V mutation
    10. plans for surgery requiring prolonged immobilization
    11. any presence or history of malignancies, personal history of benign breast diseases, family history of breast cancer
    12. abnormal PAP smear at screening examination
    13. severe dyslipoproteinaemia (LDL > 130 mg/dl and HDL < 35 mg/dl or LDL/HDL ratio > 5)
    14. diabetes mellitus with end-organ involvement or >20 years’ duration
    15. history or signs of migraine with focal neurological symptoms
    16. history of ectopic pregnancies
    17. existing cervicitis or bleeding cervical erosions
    18. abnormal uterine bleeding of unknown origin within past 6 months
    19. amenorrhea with unknown cause within past 6 months
    20. prolapse of uterine cervix, cystocele and/or rectocele
    21. severe or chronic constipation
    22. sterilized partner
    Lack of suitability for the clinical trial
    23. acute or chronic diseases which may interfere with the aims of the clinical trial
    24. history of or current drug or alcohol dependence
    25. participation in a clinical trial during the last 2 months prior to individual enrolment of the subject
    26. repeated intake of any medication during the last 2 weeks prior to individual start of treatment cycle of the subject which might interfere with absorption, efficacy or safety of the IMPs
    27. repeated intake of food or beverages containing St. John's Wort after screening examination and prior to randomisation
    28. use of vitamin K within two weeks prior to individual start of treatment cycle of the subject and regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) by the subject
    29. regular use of anticoagulants or inhibitors of platelet aggregation within 1 month prior to individual start of treatment cycle of the subject
    30. use of any intramuscularly administered sexual hormone preparations within 2 months (intramuscularly administered depot preparations used once per month) or 6 months (intramuscularly administered depot preparations used once per 3 months) as well as hormonal intrauterine systems or subdermally administered preparations (e.g. single-rod subdermal contraceptive implant) within 2 months prior to individual start of treatment cycle of the subject
    31. positive pregnancy test at screening examination
    32. known or suspected pregnancy or lactating or planning pregnancy within 12 months of study entry
    33. fewer than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment
    Administrative reasons
    34. subjects suspected or known not to follow instructions
    35. subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
    36. subject who is a family member or work associate (secretary, nurse, technician, etc.) of the investigator
    37. subject who has forfeited his freedom by administrative or legal award, or who is under guardianship
    E.5 End points
    E.5.1Primary end point(s)
    bleeding pattern
    assessment of pregnancy rates
    haemostasis parameter (prothrombin fragment 1+2, APC resistance (ETP-based), APC resistance (APTT-based), d-dimer, factor VII, factor VIII, factor II, antithrombin, protein S activity, protein C activity, SHBG)
    safety (including local tolerability)
    E.5.1.1Timepoint(s) of evaluation of this end point
    bleeding pattern, pregnancy rates, haemostasis after 6 cycles
    safety (AEs, local tolerability) after 6 cycles
    E.5.2Secondary end point(s)
    safety (AEs, local tolerability)
    E.5.2.1Timepoint(s) of evaluation of this end point
    safety (AEs, local tolerability) after 13 cycles
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Bulgaria
    Moldova, Republic of
    Poland
    Russian Federation
    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
    End of the clinical trial is defined as the day of shipment of the last Case Report Form (CRF) to the company responsible for clinical biometrics.
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 670
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 670
    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 as healthy subjects will be enrolled
    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 Decision2016-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-03
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