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    Summary
    EudraCT Number:2021-001424-17
    Sponsor's Protocol Code Number:CF113-302
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-07-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-001424-17
    A.3Full title of the trial
    A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-CF113 in the treatment of endometriosis versus placebo after 3 medication cycles followed by 3 open-label medication cycles
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in women suffering from endometriosis to test the drug LPRI-CF113 (drospirenone) during 6 months of treatment
    A.4.1Sponsor's protocol code numberCF113-302
    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 AddressC/Manuel Pombo Angulo, 28, 3rd floor
    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 nameDrospirenone
    D.3.2Product code LPRI-CF113
    D.3.4Pharmaceutical form Film-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.3.9.2Current sponsor codeLPRI-CF113
    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 typerange
    D.3.10.3Concentration number2.8 to 4
    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 placeboFilm-coated 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
    Endometriosis
    E.1.1.1Medical condition in easily understood language
    Endometriosis is a condition in which tissue similar to the lining of the uterus (the endometrium, womb) grows outside the uterus.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    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 efficacy of LPRI-CF113 in the management of Endometriosis Associated Pelvic Pain (EAPP) as assessed on a numeric rating scale (NRS).
    E.2.2Secondary objectives of the trial
    To assess the efficacy of LPRI-CF113 versus placebo in terms of response to treatment.
    To assess the safety and tolerability of LPRI-CF113 in comparison to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Postmenarcheal and premenopausal female subjects ≥ 15 and ≤ 45 years of age at screening, not seeking pregnancy.
    2. Endometriosis was diagnosed by laparoscopy at least 6 weeks before
    Visit 1a and either
    a. histological confirmation was documented, OR
    b. in cases where histological confirmation is not available, the complete
    laparoscopy report with a visual confirmation of the diagnosis is
    available to the investigator.
    3. EAPP of ≥ 3 points on an NRS during the last 3 months before screening.
    4. Be able and willing to provide written informed consent or assent before any trial-related procedure will be performed.
    5. In females not using a hormonal contraceptive at screening: regular menstrual cycles (i.e. cycle length between 21 and 35 days) during the last 3 months before screening.
    6. Willing to agree to one wash-out cycle of hormonal therapies, if applicable.
    7. Willing to use one agreed NSAID or paracetamol as rescue medication throughout the trial. No switching or start of an additional pain killer should be planned after Visit 1a until the end of the trial.
    8. Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening, in a sitting position after 5 minutes of rest.
    9. Willing to use IP for six 28-day cycles.
    10. Willing to use reliable non-hormonal contraceptive methods (condoms, female or male sterilisation or sexual abstinence [if in line with the preferred and usual lifestyle of the subject]) during the course of the trial.
    11. Be in good physical (apart from endometriosis) and mental health according to medical history and general physical examination performed at screening.
    12. Willing to adhere to the prohibitions and restrictions specified in the protocol.
    13. Agree not to participate in any other clinical trials during the course of this trial.

    Inclusion criteria at Visit 1b:
    14. Have completed the e-diary in accordance with the e-diary instructions and with no more than 1 missed entry per each week during the last 28 days before Visit 1b.
    15. Have regular menstrual cycles (i.e. cycle length between 21 and 35 days) during the screening period.
    16. A mean EAPP score of ≥ 3 points on an NRS within the last 28 days before Visit 1b as assessed by e-diary entries.
    E.4Principal exclusion criteria
    1. Ongoing pregnancy, wish for pregnancy, and breastfeeding subjects.
    2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of IP or trial e-diary.
    3. Abnormal finding on pelvic, breast or ultrasound examination other than those related to endometriosis that in the investigator’s opinion contraindicates participation in the trial.
    4. Pelvic pain not caused by endometriosis (e.g. interstitial cystitis,
    presumptive adenomyosis, fibroids, post-surgery pain, etc.). In case of
    a recent (< 3 months prior to Visit 1a) surgery, incl. low invasive
    laparoscopy, the investigator should confirm that the subject has fully
    recovered.
    5. Any other pathology associated with chronic pain (e.g. fibromyalgia, chronic back pain, chronic headaches, etc.).
    6. Laboratory values, heart rate and/or electrocardiogram assessment at screening which are considered clinically significant and which in the opinion of the investigator would be detrimental for participation in the trial.
    7. Known contraindication to the use of LPRI-CF113:
    a) Active venous thromboembolic disorder.
    b) Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
    c) Severe renal insufficiency or acute renal failure.
    d) Known or suspected sex-steroid sensitive malignancies.
    e) Undiagnosed vaginal bleeding.
    f) Hypersensitivity to the active substance or to any of the excipients.
    8. Currently ongoing conditions or previous history of:
    a) Cerebral-vascular or coronary-artery disease which includes myocardial infarction, angina pectoris.
    b) Valvular heart disease with thrombogenic complications.
    c) Headaches with focal neurological symptoms.
    d) Known or suspected carcinoma of the breast.
    e) Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease).
    f) Diabetes mellitus with vascular involvement.
    g) Adrenal insufficiency.
    h) History of cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
    i) Hyperkalaemia.
    j) Hysterectomy.
    9. Major surgery with more than 7 days of immobilisation within the 2 weeks prior to screening.
    10. Uncontrolled concomitant diseases (i.e. not on a stable treatment dose for at least 2 months before screening).
    11. Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to screening).
    12. Known or suspected human immunodeficiency virus (HIV) and/or hepatitis infection at screening.
    13. Received a dose of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) within the last 10 months prior to screening, or received any combined injectable contraceptive (e.g. Cyclofem®) within the last 6 months prior to screening, or no spontaneous menses since last injection.
    14. Long-term treatment (> 7 consecutive days within a month prior to Visit 1b) of any medication that might interfere with the efficacy of hormonal contraceptives, e.g.:
    a) Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone, lamotrigine)
    b) Potent inhibitors of CYP3A4 (fluconazole, ketoconazole, itraconazole or voriconazole).
    c) Barbiturates
    d) Antibiotics (such as rifampicin)
    e) HIV medication (such as ritonavir, nelfinavir, neviparine and efavirenz)
    f) Hepatitis C virus (HCV) medication (e.g. boceprevir, telaprevir)
    g) Macrolides (clarithromycin and erythromycin)
    h) Bosentan
    i) Griseofulvin
    j) Verapamil
    k) Diltiazem
    l) Cyclosporin
    m) St. John’s wort (hypericum perforatum)
    n) Opioids
    15. Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within the month prior to screening.
    16. Progestin-releasing intrauterine device (IUD) or contraceptive implant received or in place within the last 2 months prior to screening.
    17. Known inherited or acquired predisposition to venous thromboembolism (VTE) e.g. factor V Leiden, prothrombin mutation, antiphospholipid antibodies) or bruising within the last 12 months prior to screening.
    18. Previous or current use of a drospirenone-containing progestogen-only-pill.
    19. Evidence or history of clinically significant psychiatric illness or suicide risk according to the diagnosis from a psychiatrist.
    20. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive.
    21. Participation in any other drug or medical device investigational trial
    or observational study within the past 30 days (or five half-lives of IP
    whichever is longer) prior to Visit 1a until last visit.
    22. Subject is a member of the investigator’s or sponsor’s staff or a relative or family member thereof.
    23. Any condition that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial.
    24. 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)
    Changes from baseline in EAPP by the assessment of subject reported pain score on an NRS after 3 medication cycles.

    Intercurrent events (ICEs) and strategies
    • Change in rescue medication during 3 medication cycles compared to baseline.
    • Treatment non-compliance (< 80% or > 120%).
    • Discontinuation of treatment (due to lack of efficacy, adverse events [AEs] or safety concerns).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of days corresponding to subjects average menstruation cycle duration, prior to and including Day 28 of medication cycle 3 (or last intake of IP in case of early discontinuation).
    E.5.2Secondary end point(s)
    1. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in dysmenorrhoea (assessed via NRS pain score).
    2. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in NMPP (assessed via NRS pain score).
    3. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in rescue medication intake.
    4. Changes after 1 and 6 medication cycle(s) compared to baseline in EAPP (assessed via an NRS pain score).
    5. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in dyspareunia.
    6. Number and percentage of subjects with amenorrhoea.
    7. Vaginal bleeding pattern
    8. The number and percentage of responders at 3 months (responder will be defined by a 50% EAPP reduction measured through an NRS).
    9. Withdrawals due to lack of efficacy (pain relief).
    10. Changes after 3 and 6 medication cycles compared to baseline in quality of life (30-item Endometriosis Health Profile Questionnaire [EHP-30]).
    11. Patient’s Global Impression of Change (PGIC).
    12. Adverse events.
    13. Mean absolute and relative changes in laboratory values.
    14. Vital signs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 6 medication cycles, respectively
    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 Yes
    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) 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 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 Yes
    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 EEA17
    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
    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
    Last visit last subject
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 20
    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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 226
    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 No
    F.3.2Patients Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 236
    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)
    After the end of the trial, the subjects will be treated according to local standard practice.
    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 Decision2022-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-25
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