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    The EU Clinical Trials Register currently displays   37995   clinical trials with a EudraCT protocol, of which   6234   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-000915-26
    Sponsor's Protocol Code Number:000295
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2018-11-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-000915-26
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of quinagolide extended-release vaginal ring on reduction of lesions, assessed by high-resolution MRI, in women with endometrioma, deep inflitrating endometriosis and/or adenomyosis.
    A.4.1Sponsor's protocol code number000295
    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 SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 supportFerring Pharmaceuticals
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointGlobal Clinical R&D
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.6E-mailDK0-Disclosure@ferring.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 nameQuinagolide
    D.3.2Product code FE999051
    D.3.4Pharmaceutical form Vaginal delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQUINAGOLIDE
    D.3.9.1CAS number 94424-50-7
    D.3.9.2Current sponsor codeFE999051
    D.3.9.4EV Substance CodeSUB04163MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1080
    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 Yes
    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 placeboVaginal delivery system
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Deep infiltrating endometriosis, endometrioma and/or adenomyosis.
    E.1.1.1Medical condition in easily understood language
    Endometriosis
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014787
    E.1.2Term Endometriosis of uterus
    E.1.2System Organ Class 100000004872
    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 effect of quinagolide vaginal ring compared to placebo on reduction of lesions for endometrioma, deep infiltrating endometriosis (DIE) and adenomyosis assessed by high-resolution magnetic resonance imaging (MRI)
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of quinagolide vaginal ring compared to placebo on reducing the sizes of endometrioma assessed by transvaginal ultrasound (TVU)
    - To evaluate the effect of quinagolide vaginal ring on patient reported outcomes (PROs)
    - To evaluate the plasma concentrations of quinagolide and its metabolites
    - To evaluate the effect of quinagolide vaginal ring on serum endocrine parameters
    - To evaluate the effect of quinagolide vaginal ring on menstrual bleeding pattern
    - To evaluate the safety profile of quinagolide vaginal ring including adverse events and routine safety laboratory parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent signed and dated prior to any trial-related procedures.
    2. In good physical and mental health to participate in the trial.
    3. Pre-menopausal females between the ages of 18-45 years (both inclusive) at the time of signing the informed consent.
    4. A menstrual cycle of 24-35 days (both inclusive) based on observation made in the absence of drugs that can affect the cycle length (e.g. oral contraceptives) prior to the screening visit.
    5. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening.
    6. Confirmation of deep infiltrating endometriosis (DIE) (lesion size ≥15 mm), endometrioma
    (≥20 mm) or adenomyosis (maximum junctional zone thickness ≥12 mm or focal lesion ≥15 mm) by high-resolution MRI at screening.
    7. Transvaginal ultrasound documenting a uterus with no abnormalities of endometrium and
    presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal
    fibroids or polyps are exclusionary.
    8. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if
    adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or
    true abstinence of the subject (sporadic sexual intercourse with men requiring condom use).
    9. Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomisation to the end of treatment.
    10. Documentation of normal cervical cytology or negative human papilloma virus (HPV) results for high-risk viral subtypes upon presence of atypical squamous cells of undetermined significance, based on test(s) performed within 24 months of randomisation.
    11. Willing and able to comply with trial procedures, including attending scheduled visits and adherence to treatment plan.
    E.4Principal exclusion criteria
    1. Use of depot medroxyprogesterone acetate (MPA) or birth control implants (e.g.
    IMPLANON) within 10 months prior to the screening visit.
    2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
    3. Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
    4. Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal
    patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
    5. Undiagnosed abnormal vaginal bleeding within the last 3 months of the screening visit.
    6. History of recurrent bacterial, fungal or viral vaginal infection (i.e. ≥4 episodes within a
    year).
    7. History of malignancy within 5 years prior to the screening visit, except for adequately
    managed basal cell carcinoma and squamous cell carcinoma of the skin.
    8. History of orthostatic hypotension or recurrent syncope.
    9. History of mental illness including occurrence of acute psychosis and bipolar schizophrenia
    (except for well-controlled mild or moderate anxiety and/or depression with no changes to
    interventions for 3 months prior to the screening visit).
    10. History of sudden sleep onset episodes.
    11. Known diagnosis of impulse control disorders including pathological gambling, compulsive
    buying, hypersexuality, and binge eating.
    12. Known positive results of Human Immunodeficiency Virus (HIV) antibody tests.
    13. Any other incidental, clinically significant abnormal findings than endometriotic /
    adenomyotic lesions identified at the screening MRI assessment (e.g. suspected tumour).
    14. Any clinically significant abnormal findings from vital signs, blood tests of haematology and
    clinical chemistry at screening, including alanine aminotransferase (ALT) >2.5 times upper
    limit of normal (ULN) or bilirubin >1.5 times ULN or creatinine >1.5 times ULN.
    15. Any clinically significant abnormal findings at physical examination at screening.
    16. Any vaginal or vulvar lesions that would interfere with vaginal ring usage.
    17. Current pregnancy as confirmed by a positive serum pregnancy test at screening or planning
    a pregnancy within the duration of the trial, or currently breast-feeding or less than 6 months
    post-partum prior to the screening visit.
    18. Planned surgical treatment of endometriosis or adenomyosis during the duration of the trial.
    19. Continuous use of strong opioids (e.g. morphine) and/or illicit drugs (e.g. marijuana and
    amphetamine) for more than 2 weeks within 6 months prior to the screening visit.
    20. Alcohol abuse (>14 units of alcohol a week) within 2 years prior to the screening visit.
    21. Previous or current participation in a clinical trial involving a non-registered investigational
    medicinal product within 1 month of screening. If the trial involves a hormonal drug, the
    exclusion criteria 1-4 shall apply.
    22. Contraindications to MRI such as having internal/external metallic devices and/or
    accessories (e.g. cardiac pacemakers and leg braces).
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the sizes (mm) of endometrioma, DIE and adenomyosis lesions summed by
    type on MR images at cycle 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Cycle 4
    E.5.2Secondary end point(s)
    - Percentage of changes in the sizes of endometrioma, DIE and adenomyosis lesions summed
    by type on MR images at cycle 4
    - Proportion of lesions by type with a decrease in a size of ≥5 mm on MR images at cycle 4
    - Proportion of subjects with a lesion of any type decreased in a size of ≥5 mm on MR images at cycle 4
    - Number of new or disappearing endometrioma, DIE and adenomyosis lesions summed by
    type on MR images at cycle 4
    - Changes in the volumes (mm3) of endometrioma and DIE lesions summed by type on MR images at cycle 4
    - Changes in the sizes of endometrioma assessed by TVU at cycle 4
    - Changes in the mean individual and total symptom and sign severity of scores of the Biberoglu and Behrman (B&B) scale at cycle 4
    - Changes in the Numerical Rating Scale (NRS) pain scores per cycle at cycles 1, 2, 3 and 4
    - Changes in the Endometriosis Health Profile-30 (EHP-30) scores at cycles 2 and 4
    - Changes in the menstrual bleeding pattern over 4 cycles
    - Serum levels of prolactin, thyroid-stimulating hormone (TSH), insulin-like growth factor-1 (IGF-1) during cycle 1, at cycles 2 and 4
    - Plasma concentrations of quinagolide and its metabolites during cycles 1 to 4
    - Changes in clinical chemistry and haematology parameters and proportion of subjects with
    markedly abnormal changes
    - Frequency and intensity of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cycle 4
    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 Yes
    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) 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 trial is defined as the date of approximately 1 month after LPLV, i.e. when the follow-up phone call is made.
    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 months11
    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 months11
    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: 72
    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 No
    F.3.2Patients Yes
    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 Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    No specific follow-up procedures are defined after the end-of-trial, except for safety follow-up procedures for subjects becoming pregnant during treatment and for subjects with unresolved adverse events classified as serious or considered to have a reasonable possible causality to the IMP.
    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 Decision2019-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-10
    P. End of Trial
    P.End of Trial StatusRestarted
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