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    Summary
    EudraCT Number:2020-000866-41
    Sponsor's Protocol Code Number:2019001_mife50
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-02-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2020-000866-41
    A.3Full title of the trial
    Combined Phase II/ III Multicentre Single-arm Trial of a Mifepristone 50 mg as a weekly Contraceptive
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mifepristone 50mg as a weekly Contraceptive
    A.3.2Name or abbreviated title of the trial where available
    Mife50
    A.4.1Sponsor's protocol code number2019001_mife50
    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 SponsorWomen on Web International Foundation
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGrand Challenges Canada
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWomen on Waves
    B.5.2Functional name of contact pointRebecca Gomperts
    B.5.3 Address:
    B.5.3.1Street AddressDomselaerstraat 14
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1093MA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31652052561
    B.5.6E-mailgomperts@womenonwaves.org
    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 Ginestril 50mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNijpharm JSC (Russia), STADA Group
    D.2.1.2Country which granted the Marketing AuthorisationGeorgia
    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 nameGinestril 50mg Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Prevention of unwanted pregnancy
    E.1.1.1Medical condition in easily understood language
    Prevention of unwanted pregnancy
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    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 contraceptive efficacy and safety of once a week mifepristone 50 mg.
    E.2.2Secondary objectives of the trial
    To determine the side-effects and acceptability of once a week mifepristone 50 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. no desire to become pregnant within the next 13 months
    2. provision of signed and dated informed consent form for participation in the study
    3. stated willingness to comply with all study procedures and availability for the duration of the study
    4. female, aged 18-35
    5. have a normal menstrual cycle of 25-35 days cycles which differ by no more than 3 days with less than 7 days of bleeding
    6. at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss
    7. be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month
    8. be willing to use the study drug as the only method of contraception over the course of the study - if the potential participant is taking another contraceptive, they would have to stop and have one menstruation to be included in the trial
    9. ability to take oral medication and be willing to adhere to the contraceptive regimen
    E.4Principal exclusion criteria
    1. current pregnancy
    2. within 3 months of delivery
    3. abnormal cervical smear or within year before
    4. known infertility or subfertility
    5. history of ectopic pregnancy
    6. any previous or current malignancy including breast cancer
    7. abnormal liver enzymes
    8. irregularities in endometrium
    9. retained products of conception after miscarriage or abortion
    10. signs of endometritis
    11. known allergic reactions to mifepristone
    12. lactation
    13. using high doses of corticosteroids or any drugs that may interact with mifepristone - these include hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)
    14. treatment with another investigational drug
    15. unable to comply with the trial protocol
    E.5 End points
    E.5.1Primary end point(s)
    1. Occurrence of pregnancy during treatment caused by method failure.
    2. Proportion of women with endometrium thickness>15 mm, endometrium with irregular cystic appearance on US at baseline months 3, 6, months 9, months 13 and 2 months after end of treatment.
    3. Proportion of women with ALAT, ASAT and bilirubin elevation three times above normal at baseline, months 3, months 6, months 9, months 13 and 2 months after end of treatment.
    4. Proportion of women with adverse event / serious adverse event.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As indicated above
    E.5.2Secondary end point(s)
    1. Occurrence of pregnancy during treatment caused by user failure.
    2. Proportion of women with blood hormone levels abnormalities.
    3. Proportion of women with anovulatory cycles.
    4. Proportion of women with endometrial changes (PAEC) confirmed by biopsy at baseline, months 3, months 6, months 9 and 2 months after end of treatment.
    5. Proportion of women with normal haemoglobin value at baseline, 3 months, 6 months, 9 months, 13 months and 2 months after end of treatment.
    6. Mean value of quality of life questionnaire (EQ-5D-5L) at baseline, 3 months, 6 months, 9 months, 13 months and 2 months after end of treatment.
    7. Proportion of women who uses antidepressants at baseline and during the study.
    8. Proportion of women with dysmenorrhea (diary continued measurement) during the study.
    9. Proportion of women with acne occurrence (diary continued reporting) during the study.
    10. Proportion of women with side-effects (headache, nausea, breast pain, dry eyes) (diary continued reporting) during the study.
    11. Mean weight changes at 3 months, 6 months, 9 months, 13 months and 2 months after end of treatment compared to baseline.
    12. Proportion of women with vaginal bleeding (diary continued measurement)
    13. Libido: mean value of Female Sexual Function Index (FSFI) at baseline, 3 months, 6 months, 9 months and 2 months after end of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As indicated above
    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) Yes
    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 Yes
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Georgia
    E.8.7Trial has a data monitoring committee Yes
    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.8.9.2In all countries concerned by the trial years3
    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: 949
    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 Yes
    F.3.2Patients No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 949
    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
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Georgia
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