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    Summary
    EudraCT Number:2020-000089-41
    Sponsor's Protocol Code Number:FCH-LNG-BW-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-03-30
    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 number2020-000089-41
    A.3Full title of the trial
    Randomized, Open-Label, Multicenter Proof-of-Principle Study to Assess the Effect of Single Doses of 1.5 mg and 3.0 mg Levonorgestrel During the Mid-Follicular Phase on the Inhibition of Ovulation in Women Across Body Mass Index Categories
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to compare the effect of a single dose of 1.5 mg and 3 mg levonorgestrel on delaying ovulation in women with regular menstrual cycles having different body weights.
    A.4.1Sponsor's protocol code numberFCH-LNG-BW-01
    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 SponsorFoundation Consumer Healthcare (FCH)
    B.1.3.4CountryUnited States
    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 supportFoundation Consumer Healthcare
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointPascale Servais
    B.5.3 Address:
    B.5.3.1Street AddressLozenberg 19
    B.5.3.2Town/ citySt. Stevens-Woluwe
    B.5.3.3Post code1932
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322 80884 40
    B.5.6E-mailPascale.Servais@ppdi.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 Yes
    D.2.1.1.1Trade name Levonorgestrel 1.5 mg Tablet (Authorized Generic)
    D.2.1.1.2Name of the Marketing Authorisation holderFoundation Consumer Healthcare, LLC
    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 1.5 mg Tablet (Authorized Generic)
    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 codeLNG-EC
    D.3.9.3Other descriptive nameLEVONORGESTREL
    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
    Inhibition of Ovulation in Women Across Body Weight Categories During the Mid-Follicular Phase
    E.1.1.1Medical condition in easily understood language
    Inhibition of Ovulation in Women Across Body Weight Categories during the time between the first day of the period and 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 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082354
    E.1.2Term Emergency contraceptive pill
    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
    · To evaluate the possibility that inhibition of ovulation is affected by BMI in women using the current dose of 1.5 mg LNG-EC
    · To evaluate the effect of the 3.0mg LNG EC dose on inhibition of ovulation response across each of the BMI groups
    E.2.2Secondary objectives of the trial
    - To evaluate the possibility that the ovarian activity is affected by BMI in women using LNG-EC
    - To assess hormone levels between BMI groups at each LNG dose level
    - To evaluate any spontaneously occurring luteinized unruptured follicle (LUF) at each LNG dose level
    - To evaluate differences in the pharmacokinetics of LNG-EC between different BMI groups
    - To assess the safety and tolerability for each LNG dose level
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated ICF
    2. Stated willingness to comply with all study procedures including attendance at the study center for all study visits as scheduled and completion of diary
    3. Healthy adult, ovulatory female
    4. Aged at least 18 years but not older than 40 years
    5. Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
    6. Occurrence of regular menstrual cycles that typically happen every 24-35 days when not using hormonal contraception (established by medical history over the past 3 months) and that should preferably be of consistent duration within this range. In addition, subject must have a midluteal P4 value of ≥12 nmol/L to confirm baseline ovulatory status during the screening visit
    7. Both ovaries must be present. If both ovaries are not visible on the screening TVU, a confirmatory TVU may be performed on the same day or on a subsequent day within the Screening Visit allowance window.
    8. Does not want to become pregnant during the study
    9. Use of 1 of the accepted contraceptive regimens from the Screening Visit through to the end of the study. An acceptable method of contraception includes 1 of the following:
    · Abstinence from heterosexual intercourse
    · Intrauterine device (IUD; without hormones, i.e. copper IUD without drug release)
    · Male partner using condom with spermicide or male condom with use of a vaginal spermicide (gel, foam, or suppository)
    · Male partner vasectomized at least 6 months prior to the first study drug administration
    · Cervical cap with spermicide
    or
    · Female sterilization procedure
    10. At least 1 bleeding episode consistent with menses must have occurred since last use, if the subject has recently used non-injectable hormonal contraception
    11. Most recent injection must have occurred at least 6 months before the Pre-Screening Visit, and the subject must have had at least 1 normal menstrual cycle (2 consecutive menses), if there is a history of DepoProvera use
    12. At least 2 menstrual bleeds must have occurred since the pregnancy ended, if the subject is postpartum or postabortal
    13. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by the investigator
    14. No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by the investigator
    15. No clinically significant findings on the screening pelvic examination, as determined by the investigator
    E.4Principal exclusion criteria
    1. Currently lactating/breastfeeding or is within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding
    2. Is pregnant according to the pregnancy test at screening or prior to the first study drug administration
    3. Currently using any systemic contraceptives (e.g. oral, patch, vaginal ring, injections, implants or hormone-releasing IUD) or any hormone replacement therapy
    4. Currently anovulatory (skipped ovulation) as confirmed by a midluteal P4 value of <12 nmol/L at the Screening Visit
    5. History of hypersensitivity to LNG or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs (based on medical history, subject's description, and Investigator's interpretation)
    6. Presence or history of significant gastrointestinal, liver, or kidney disease, or surgery (including bariatric surgery associated with malabsorption) that may affect drug bioavailability
    7. Presence or history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, gastrointestinal, renal, urinary, skeletal, dermatologic disease, or breast cancer. Any finding of breast mass during the physical examination will lead to exclusion, and the subject will be referred to her physician for further evaluation
    8. Presence of clinically significant ECG abnormalities at the Screening Visit, as determined by the Investigator
    9. Presence of abnormal/unresolved vaginal bleeding
    10. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency, or glucose-galactose malabsorption
    11. Receiving maintenance therapy with any drug if not stable or not controlling the condition or potentially interfering with the menstrual cycle or ovulation, as assessed by the investigator
    12. Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, acute or chronic intake of excessive alcohol, or chronic daily use of marijuana)
    13. Any clinically significant illness in the 28 days prior to the first study drug administration
    14. Subjects who never had sexual intercourse
    15. History of thrombophlebitis
    16. Use of any prescription drugs (including all hormonal contraceptives and hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would interfere with the study treatment or put into question the status of the participant as healthy
    17. Concomitant use of drugs and herbal products that induce enzymes that metabolize progestins (including cytochrome P450 3A4 [CYP3A4]) or treatment with human immunodeficiency virus (HIV) protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (Appendix 9)
    18. Use of prescription nonsteroidal anti-inflammatory drug (NSAID) in the 28 days prior to the first study drug administration. For acute pain, acetaminophen, per product labeling (e.g. Tylenol) and over-the-counter (OTC) ibuprofen (no more than 200 mg every 6 hours) are allowed per product labeling.
    19. Any history of tuberculosis
    20. Positive test result for alcohol and/or drugs of abuse at screening or prior to each drug administration
    21. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen (HBsAG (B) (hepatitis B)), or hepatitis C virus (HCV (C)) tests (if HIV Ag/Ab combo is positive, to be verified by Western Blot or Geenius™ HIV 1/2 Confirmatory Assay; if hepatitis B surface antigen is positive, to be verified by test for immunoglobulin M antibodies against hepatitis B core antigen)
    22. Inclusion in a previous treatment group for this clinical study
    23. Has used LNG-EC within 30 days prior to Day 1 of the first treatment cycle of the study and has not had a menses since using the drug
    24. Current or recent (within 1 month of the Screening Visit) participation in any other trial of an investigational medicine or device or planning to participate in another clinical trial during this study
    25. Plans to participate in a serious caloric restriction/weight-loss diet or fasting during the course of the study
    26. Is a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
    27. Donation of plasma in the 14 days prior to the first study drug administration
    28. Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study drug administration
    29. Presence of any significant findings during the TVU screening scan that represent an abnormality such as abnormal ovaries, tumors, or fibroids that obscure visualization of the ovaries and potential ovulation process (both ovaries must be visible).
    E.5 End points
    E.5.1Primary end point(s)
    - Ovulation suppression (i.e. no occurrence of follicular rupture) within 5 days from LNG treatment administration, across each of the BMI groups (for each LNG dose level)
    - Ovulatory dysfunction (i.e. follicle rupture not preceded within 48 hours by a luteinizing hormone (LH) peak >21 IU/L), and/or followed by a luteal phase P4 peak of >3 ng/mL), across each of the BMI groups (for each LNG dose level)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At various timepoints during the study as listed in Table 1 and 2 in the protocol
    E.5.2Secondary end point(s)
    - Captured time to ovulation in the treatment periods, if ovulation occurs.
    - Grade of ovarian activity
    - Differences in hormone levels between BMI groups, for each LNG dose level
    - If a follicle persists to form an LUF, this will be recorded and followed during all post-dosing visits where a TVU is performed for each LNG dose level
    - LNG (including total, free, and bioavailable) PK profiles across the different BMI groups, for each LNG dose level
    - Observed and reported AEs, significant changes in safety laboratory parameters, and vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints during the study as listed in Table 1 and 2 in the protocol
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    Levonorgestrel 3 mg (different dose of IMP)
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The end of the study is defined as the date when the last follow-up phone call has been completed for the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days24
    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: 150
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 150
    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)
    Plans for treatment or care after the end of participation in the trial are not required for this trial.
    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 Decision2020-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-26
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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