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    Summary
    EudraCT Number:2020-000412-30
    Sponsor's Protocol Code Number:LF111/401
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-05-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-000412-30
    A.3Full title of the trial
    A multicenter, open-label, controlled study to investigate the effect of either LF111 or Drospirenone chewable tablets on bone mineral density (BMD) in adolescent and adult women in comparison with non-users of hormonal contraceptive methods.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if a hormonal birth control called Drospirenone, changes the bone density in adolescent and adult women
    A.4.1Sponsor's protocol code numberLF111/401
    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 SponsorChemo Research S.L.
    B.1.3.4CountrySpain
    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 supportChemo Research S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChemo Research S.L.
    B.5.2Functional name of contact pointChief Scientific Officer
    B.5.3 Address:
    B.5.3.1Street AddressManuel Pombo Angulo, 28
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 771 15 00
    B.5.5Fax number+34 91 766 89 63
    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 SLYND
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios León Farma, S.A.
    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 nameDrospirenone (DRSP)
    D.3.2Product code LF111
    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 INNDrospirenone
    D.3.9.1CAS number 67392-87-4
    D.3.9.4EV Substance CodeSUB06413MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboTablet
    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
    Oral contraception
    E.1.1.1Medical condition in easily understood language
    Oral contraception
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10049470
    E.1.2Term Bone density decreased
    E.1.2System Organ Class 10022891 - Investigations
    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 impact of LF111 on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods
    E.2.2Secondary objectives of the trial
    - To further evaluate the impact of LF111 on BMD and bone turnover after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods
    - To assess general safety and tolerability of LF111 in comparison to non-hormonal contraceptive methods
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female subjects with regular menstrual cycles (postmenarcheal for at least two years and premenopausal) aged 14 to 45 years. Female subjects aged between 14 to 17 years (inclusive) will only be included provided that
    a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
    b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
    2. Systolic blood pressure < 130 mmHg, diastolic blood pressure < 80 mmHg at Visit 1, in sitting position after 5 minutes of rest.
    3. Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant).
    4. Be able and willing to provide written informed consent, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures.
    5. Willing to use trial contraception for thirteen 28-day cycles (LF111 arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively.
    E.4Principal exclusion criteria
    1. Contraindications to the use of LF111 (such as active arterial or venous thromboembolic disorders, liver tumors benign or malignant, hepatic impairment, renal impairment, adrenal insufficiency, presence or history of cervical cancer or progestin-sensitive cancers, known or suspected sex-steroid sensitive malignancies, undiagnosed abnormal uterine bleeding, undiagnosed vaginal bleeding, hypersensitivity to active substance or excipient) or adverse effects due to previous contraceptive use (for the LF111 arm only).
    2. BMD Z-score below -1.5.
    3. Low trauma fracture(s) defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face and skull.
    4. Medical conditions associated with low bone mass:
    a. Metabolic bone disease such as osteogenesis imperfecta, Paget’s disease of the bone, osteomalacia/rickets
    b. Collagen vascular diseases such as Marfan’s syndrome and Erhlos-Danlos syndrome
    c. Chronic kidney disease stage 3 with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Bedside Schwartz equation for adolescents and the Modification of Diet in Renal Disease (MDRD) method for adult subjects
    d. Gastrointestinal (malabsorptive) disease including inflammatory bowel disease, gastric bypass surgery and current postgasrectomy syndrome
    e. Liver disease
    f. Abnormal bone mineral metabolism (hypocalcemia/hypercalcemia, hypophosphatemia/hyperphosphatemia, hypomagnesemia).
    5. In adolescents only: Short stature defined as height-for-age percentile less than the fifth percentile.
    6. Use of oral, transdermal, vaginal or intrauterine hormonal contraceptives in the previous month (within the previous 3 months in case of containing estrogen) or use of injectable or implantable hormonal contraceptives in the previous 6 months.
    7. Laboratory values at Screening which are considered clinically significant and which in the opinion of the investigator would be detrimental for participation in the study.
    8. Ongoing pregnancy or wish for pregnancy.
    9. Currently lactating or stopped lactating within the past year
    10. Eating disorders (e.g., anorexia nervosa, bulimia).
    11. Celiac disease.
    12. Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease).
    13. Rheumatoid arthritis.
    14. Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium.
    15. Treatment with medications that are known to decrease bone mass:
    • Glucocorticoids (oral, intravenous, chronic inhaled, chronic extensive topical) within the previous 3 months.
    Note: Subjects taking chronic oral/intravenous glucocorticoids (prednisone ≥ 2.5 mg daily for ≥ 3 months, or the equivalent) will have a washout period of 12 months.
    • Depo-medroxyprogesterone acetate within the previous 24 months (if duration of use was less than 2 years).
    Note: Subjects using depo-medroxyprogesterone acetate for a duration of use greater than 2 years will be excluded.
    • Aromatase inhibitors and/or raloxifene within the previous 24 months.
    • Anticonvulsants (phenytoin, phenobarbital, carbamazepine and valproate), anti-retroviral protease inhibitors, cyclosporine, heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitor (PPI) use, selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months.
    16. Conditions that preclude BMD measurement i.e. lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring (not willing to remove) or weight that exceeds the DXA machine limitation.
    17. Any condition that, in the opinion of the investigator, may jeopardize the trial conduct according to the protocol.
    18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
    E.5 End points
    E.5.1Primary end point(s)
    Cohort 1: Adolescents
    Mean absolute change in lumbar spine (L1-L4) Z-score from baseline to 12 months as measured by dual-energy X-ray absorptiometry (DXA)
    Cohort 2: Adults
    Mean percentage change in lumbar spine (L1-L4) BMD from baseline to 12 months as measured by DXA
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to 12 months
    E.5.2Secondary end point(s)
    Please refer to the Protocol for Cohort 1 & 2
    In Addition:
    7. Changes in body weight and body mass index (BMI)
    8. Mean absolute and relative changes in routine laboratory values from baseline to 6 months and to 12 months
    9. Mean absolute and relative changes in serum estradiol (E2) levels in the LF111 arm from baseline to 6 months and to 12 months
    10. Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to 6 months (LF111 arm only) and to 12 months
    From baseline to 12 months
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Will be compared to subjects who use non-hormonal contraceptive methods (ratio1:1)
    E.8.2.4Number of treatment arms in the trial1
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 States
    Czechia
    Poland
    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 – investigational phase
    Last subject last visit – extended post-treatment follow-up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 712
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 712
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 650
    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.4.1In the member state564
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 752
    F.4.2.2In the whole clinical trial 1362
    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)
    The investigator should arrange for the subject’s further contraceptive treatment or make an appropriate referral, as needed, at Visit 5 or at EDV. If publicly available, subjects in the LF111 treatment arm can continue with the local available LF111 if deemed most appropriate if none of the discontinuation/post-treatment follow-up criteria as detailed in the protocol.
    This arrangement is outside the trial and costs will not be covered by the sponsor.
    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 Decision2022-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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