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    Summary
    EudraCT Number:2019-001143-43
    Sponsor's Protocol Code Number:EU-KKO-LNG-02-2018
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-001143-43
    A.3Full title of the trial
    An Open-label, Multi-center, Pharmacokinetic/Pharmacodynamic Study to Evaluate the Effect of a Single Dose of Levonorgestrel 1.5 mg Tablet on Ovulation Inhibition during Mid-follicular Phase in Underweight to Obese Women
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of Levonorgestrel-Emergency Contraception Tablet on Ovulation Inhibition in groups with a BMI that ranges underweight to obese
    A.4.1Sponsor's protocol code numberEU-KKO-LNG-02-2018
    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 SponsorGedeon Richter Plc.
    B.1.3.4CountryHungary
    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 supportGedeon Richter Plc.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGedeon Richter Plc.
    B.5.2Functional name of contact pointGedeon Richter Plc
    B.5.3 Address:
    B.5.3.1Street AddressGyömrői út 19-21
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1103
    B.5.3.4CountryHungary
    B.5.4Telephone number+361 4314040
    B.5.5Fax number+361 4315415
    B.5.6E-mailRA.ctaRichter@richter.hu
    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 Levonelle® 1500 microgram tablet
    D.2.1.1.2Name of the Marketing Authorisation holderGedeon Richter Plc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLevonorgestrel
    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 INNLEVONORGESTREL
    D.3.9.1CAS number 797-63-7
    D.3.9.2Current sponsor codeLevonorgestrel
    D.3.9.4EV Substance CodeSUB08483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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
    Ovulation
    E.1.1.1Medical condition in easily understood language
    Ovulation
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10036251
    E.1.2Term Post coital contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033313
    E.1.2Term Ovulation inhibited
    E.1.2System Organ Class 100000004860
    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 shape, direction, and strength of relationship between BMI and ovulatory suppression failure (OSfailure) in women with a BMI ≥15 to ≤42 kg/m2given a single dose of Levonorgestrel 1.5 mg tablet.
    E.2.2Secondary objectives of the trial
    To assess the time to ovulation in the treatment cycle.
    To explore the effect of body weight on ovulation and pharmacokinetics (PK) of Levonorgestrel (LNG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants must have provided written informed consent before any study-related procedure was performed and after having been informed about benefits and potential risks of the clinical study, as well as details of the insurance taken out to cover the healthy women participating in the clinical study.
    2. Sex: female.
    3. Age: ≥18 years and ≤40 years.
    4. BMI: ≥15 to ≤42 kg/m2.
    5. Healthy women or women who have controlled stable chronic illness and are treated with medication, which does not interact with LNG 1.5 mg tablet, or interfere with the ovulatory cycle. Prior to enrollment of women on medication, Sponsor or designee’s approval shall be obtained.
    6. Healthy women with suitable veins for cannulation.
    7. Participants must have normal physical and gynecological examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at screening or abnormal results that are judged to be not clinically significant by the Investigator and documented as such in the electronic case report form (eCRF).
    8. Both ovaries visible upon TVUS examination at screening.
    9. Regular menstrual cycles (every 21-35 days) as established by participants’ medical history (during the past 3 months).
    10. Menstrual cycle deemed normal by the gynaecologist.
    11. Participants must agree to sexual abstinence or to use an acceptable birth control method during the study (from screening until the end of the treatment cycle).
    12. Baseline cycle of 21-35 days in length, with ovulation documented by TVUS, and a progesterone level of 12 nmol/L or greater.
    E.4Principal exclusion criteria
    1. Participants with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency, uncorrected hyper- or hypothyroidism, acute systemic infection, gynecological, renal, gastrointestinal, respiratory, cardiovascular or hematological disease.
    2. Screening liver enzyme test (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) results ≥1.5 x the upper limit of normal [ULN] or total serum bilirubin >1.5 x ULN) (one repeat measurement is allowed).
    3. Participants with gastrointestinal or renal disorders, including (but not limited to) severe malabsorption syndromes, such as Crohn's disease or colitis ulcerosa, which may interfere with the absorption, metabolism or excretion of the IMP in the Investigator’s opinion.
    4. Participants with diseases or pathological findings of genital organs which might interfere with the ovulatory process, eg, ovarian cysts >3.0 cm, history of severe endometriosis, presence or history of pelvic inflammatory disease, that may confound the study results in the Investigator’s opinion.
    5. History of current central nervous system (CNS) and/or psychiatric disorders which, in the Investigator’s opinion, may confound study results, requires treatment with prohibited medication, or may interfere with the participant’s compliance with study procedures. Participants with a diagnosis of any feeding and eating disorders are excluded.
    6. Known allergy or sensitivity to levonorgestrel or the excipients of the IMP.
    7. Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
    8. Positive tests on anti-human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M, or anti-hepatitis C virus antibodies.
    9. Known pituitary disorders, known adrenal disorders, or other significant, uncontrolled endocrine disorders including thyroid dysfunction and polycystic ovarian syndrome.
    10. History or presence of unclarified vaginal bleeding.
    11. Existing cervicitis, vaginitis, or bleeding cervical erosions. Re-screening is possible if treated for vaginitis with a negative test-of-cure.
    12. Abnormal cervical smear within 2 years of dosing or at screening.
    13. Severe or chronic constipation.
    14. History of drug abuse or positive drug or alcohol test at screening or at Treatment Day 1 prior to dosing. Exception: participants with positive urine drug screen (UDS) at screening for opiates may be enrolled at Investigator’s discretion if drug of abuse is out ruled and a legitimate cause (eg, poppy seeds consumption), that can be discontinued prior to further participation in the study, is identified and documented in source data by that Investigator.
    15. Regular use of alcohol, ie, more than 21 units of alcohol per week (1 unit = 100 mL of wine, 250 mL of beer, or 25 mL of 40% alcohol) or alcohol abuse within 6 months prior to the screening visit.
    16. Blood donation or other blood loss of more than 400 mL within the last 2 months prior to individual start of baseline cycle of the participant.
    17. Participation in a clinical study during the last 2 months or within 5 times the half-life of the IMP (whichever is longer) prior to individual start of baseline cycle of the participant.
    18. Taken strong or moderate CYP3A4 inhibitors or inducers within 30 days before administration of IMP until the last PK sampling.
    19. Use of any sex hormone containing preparations from within 1 cycle (oral, transdermal, vaginal, intrauterine), 2 months (intramuscularly administered depot preparations used once per month), or 6 months (intramuscularly administered depot preparations used once per 3 months) prior to individual start of baseline cycle of the participant. Note: intrauterine copper device/coil is acceptable.
    20. Women who use hormone-releasing intrauterine device (IUD; eg, Mirena).
    21. Positive pregnancy test at screening or at baseline (prior to dosing on Treatment Day 1).
    22. Pregnant or lactating women.
    23. Women who do not agree to the contraceptive requirements or are actively seeking pregnancy. Women who use a copper IUD do not need to use a barrier method additionally.
    24. Participants with risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy).
    25. Heavy smoker (11 or more cigarettes per day or equivalent nicotine exposure).
    26. Actively seeking or involved in a weight loss program.
    27. Lack of ability to comply with the study procedures based on the Investigator's judgement.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is ovulatory suppression failure (OSfailure) defined as ovulation within 5 days from IMP administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days post IMP Administration f
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of this study are:

    Time to ovulation in treatment cycle.

    Endocrine status (hormone levels of LH, follicle stimulating hormone [FSH], P4 and estradiol [E2]).
    Dominant follicular diameter (assessed by TVUS).

    Other Secondary End Point

    LNG plasma concentration–time data
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through out 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 No
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    United Kingdom
    United States
    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
    Last Subject Last Visit
    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 days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days16
    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: 520
    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 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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 520
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-10-11
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