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    Summary
    EudraCT Number:2019-001877-97
    Sponsor's Protocol Code Number:LPRI-424/302
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-15
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2019-001877-97
    A.3Full title of the trial
    A multicentre, double-blind, double-dummy, randomised trial on the contraceptive efficacy, tolerability and safety of LPRI-424 (dienogest 2 mg / ethinyl estradiol 0.02 mg) during nine cycles in comparison with drospirenone 3 mg / ethinyl estradiol 0.02 mg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study for testing the contraceptive efficacy, tolerability and safety of dienogest 2 mg / ethinyl estradiol 0.02 mg during nine cycles in comparison with drospirenone 3 mg / ethinyl estradiol 0.02 mg
    A.4.1Sponsor's protocol code numberLPRI-424/302
    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 number0034917711500
    B.5.5Fax number0034917668963
    B.5.6E-mailEnrico.Colli@exeltis.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 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 nameDienogest 2.00 mg / Ethinyl Estradiol 0.02 mg
    D.3.2Product code LPRI-424
    D.3.4Pharmaceutical form Prolonged-release 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 INNDIENOGEST
    D.3.9.1CAS number 65928-58-7
    D.3.9.4EV Substance CodeSUB07108MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    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 number0.02
    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 Velmari 3 mg/0,02 mg potahované tablety
    D.2.1.1.2Name of the Marketing Authorisation holderExeltis Czech s.r.o.
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    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 Coated 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.3.9.3Other descriptive nameDROSPIRENONE
    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 number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    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 number0.02
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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 for females aged 18-45
    E.1.1.1Medical condition in easily understood language
    Oral contraception for females aged 18-45
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10030970
    E.1.2Term Oral contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the contraceptive efficacy of LPRI-424
    E.2.2Secondary objectives of the trial
    To demonstrate the safety and tolerability of LPRI 424 in comparison to DRSP 3 mg / EE 0.02 mg, especially regarding bleeding pattern
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Special clinical laboratory parameters (haemostatic variables, carbohydrate metabolism and bone mineral density biomarkers) for a subset of subjects (at least 40 evaluable subjects per treatment group)
    E.3Principal inclusion criteria
    1.Sexually active, postmenarcheal and premenopausal female subjects, at risk of pregnancy, aged between 18-45 years (inclusive) at the time of trial enrolment.
    2.Women who
    a.have never used hormonal contraceptives before consent (naïve users),
    b.have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users)
    or
    c.directly switch from another hormonal contraceptive (switchers).
    3.Only for subjects who were not pregnant and did not use hormonal contraception during the last six months before consent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months.
    4.Only for women who were pregnant within the last six months before consent: At least three complete menstrual cycles after pregnancy.
    5.At screening, systolic blood pressure ≤ 140 mm Hg and diastolic blood pressure ≤ 90 mm Hg.
    6.Be able and willing to provide written informed consent prior to undergoing any trial-related procedure.
    7.Willing to use trial contraception for nine 28-day cycles.
    8.Be willing to have intercourse in each cycle of the trial without the need to use back-up contraception.
    9.Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile.
    10.Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed).
    E.4Principal exclusion criteria
    1.Pregnancy.
    2.Wish for pregnancy.
    3.Breastfeeding.
    4.Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
    5.History of infertility.
    6.Body Mass Index (BMI) < 18 kg/m2 or BMI >30 kg/m2.
    7.Current smokers with age > 35 years (at the time of trial enrolment).
    8.Abnormal finding on pelvic, breast or ultrasound examination that in the investigator’s opinion contraindicates participation in the trial.
    9.Women ≥21 years of age with a Papanicolaou (Pap) smear reading low grade of squamous intraepithelial lesion (LGSIL) or higher at screening (or six months prior to screening date). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASC-US) can be used as an adjunctive test. Subjects with ASC-US can be included if they are negative for high-risk HPV strains. Subjects < 21 years of age do not require a Pap smear.
    10.Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including:
    a.Presence or risk of a venous thromboembolism (VTE)
    b.Presence or risk of an arterial thromboembolism (ATE)
    c.Presence or history of pancreatitis, if it is associated with severe hypertriglyceridemia
    d.Presence or history of liver diseases in which liver function has not returned to normal (also Dubin-Johnson and Rotor syndrome)
    e.Current or previous liver tumours
    f.Known or suspected sex hormone-dependent malignant tumours (e.g., breast, genital organs or endometrium)
    g.Undiagnosed vaginal bleeding
    h.Unexplained amenorrhoea
    i.Concomitant use of medicinal products containing ombitasvir / paritaprevir / ritonavir or dasabuvir
    j.Severe renal insufficiency or acute renal failure.
    11.Uncontrolled thyroid disorder (i.e., not on stable dose of thyroid replacement for at least than two months at the time of consent).
    12.Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months at the time of consent).
    13.Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent).
    14.Known HIV infection.
    15.Known current or chronic hepatitis B or C.
    16.Known HPV infection with strains 16, 18 or other high-risk strains as per screening examination
    17.Less than 3 menses after discontinuing dosing of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) or any combined injectable contraceptive (e.g. Cyclofem®) prior to consent.
    18.Long-term treatment (longer than seven consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives, e.g.:
    a.Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate)
    b.Barbiturates (e.g. primidone)
    c.Specific antibiotics (such as rifampicin [tuberculosis infection], griseofulvin [fungal infections])
    d.HIV medication (such as ritonavir, neviparine and efavirenz)
    e.Bosentan
    f.St. Johns wort (hypericum perforatum)
    g.Metoclopramide
    19.Prohibited medication including the use of oestrogens, progestogens, strong microsomal enzyme-inducing drugs (intensive and moderate frequency).
    20.Prohibited medications that may increase serum potassium (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin and aldosterone antagonists).
    21.Administration of medication containing human chorionic gonadotropin (hCG) within a month prior to V1b.
    22.Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent.
    23.Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures.
    24.Evidence or history of clinically significant psychiatric illness, such as major depression or schizophrenia, that in the investigator’s opinion contraindicates participation in the trial.
    25.Planned surgery during participation in this trial requiring withdrawal of an oral contraceptive.
    26.Participation in another trial of an investigational drug or device in parallel to the current trial or less than 90 days before consent, or previous participation in a clinical trial with LPRI 424 or LPRI-421 and dispensed trial medication.
    27.Subject is a member of the investigator’s or sponsor’s staff or a relative or family member thereof.
    28.Any condition that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial.
    29.Systemic lupus erythematosus, chronic inflammatory bowel disease (Crohn´s disease or ulcerative colitis) or sickle cell disease.
    30. Severe Covid-19 disease or less than 3 months after hospitalisation due to Covid-19 disease.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Pearl Index (PI) in women aged ≤ 35 years (at the time of trial
    enrolment)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After trial termination
    E.5.2Secondary end point(s)
    1.Overall PI in all women and in women aged > 35 years (at the time of trial enrolment)
    2.PI after correction for back-up contraception and sexual activity (evaluable cycles) in all women
    3.PI after correction for back-up contraception and sexual activity (evaluable cycles) in women aged ≤ 35 years and in women aged > 35 years (at the time of trial enrolment)
    4.PI for method failures in all women
    5.PI for method failures in women aged ≤ 35 years and in women aged > 35 years (at the time of trial enrolment)
    6.Pregnancy ratio by life table analysis in all women
    7.Pregnancy ratio by life table analysis in women aged ≤ 35 years and in women aged > 35 years (at the time of trial enrolment)
    Safety/Tolerability:
    8.AEs
    9.Vital signs
    10.ECG
    11.Clinical laboratory parameters
    12.Special clinical laboratory parameters (in a subset of at least 40 subjects per treatment group):
    •Haemostatic variables
    •Carbohydrate metabolism
    •Bone mineral density biomarkers
    13.Physical examination
    14.Gynaecological examination
    15.Transvaginal ultrasound examination
    16.Mastodynia/mastalgia and dysmenorrhoea characteristics as well as cervical cytology
    17.Bleeding pattern
    18.IMP acceptability
    19.Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After trial termination
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double-dummy
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    Czechia
    Germany
    Hungary
    Poland
    Portugal
    Slovakia
    Spain
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 1018
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 918
    F.4.2.2In the whole clinical trial 1018
    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 V4 or at EDV. Consecutive contraceptives should be started after last IMP intake (last placebo pill) and should be used at least until V6/follow-up. 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 Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-22
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