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    Summary
    EudraCT Number:2017-003310-74
    Sponsor's Protocol Code Number:MVT-601-3003
    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:2017-11-23
    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 number2017-003310-74
    A.3Full title of the trial
    LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the long term Efficacy and Safety of Relugolix in Women With Heavy Menstrual Bleeding Associated with Uterine Fibroids
    A.4.1Sponsor's protocol code numberMVT-601-3003
    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 SponsorMyovant Sciences GmbH
    B.1.3.4CountrySwitzerland
    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 supportMyovant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMyovant Sciences GmbH
    B.5.2Functional name of contact pointVP of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address2000 Sierra Point Parkway
    B.5.3.2Town/ cityBrisbane
    B.5.3.3Post codeCA 94005
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650 238-0250
    B.5.6E-mailLIBERTY@myovant.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 nameRelugolix
    D.3.2Product code TAK-385, RVT-601
    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 INNRelugolix,
    D.3.9.1CAS number 737789-87-6
    D.3.9.2Current sponsor codeMVT-601
    D.3.9.3Other descriptive nameCAS name: Urea, N-[4-[1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno[2,3-d]pyrimidin-6-yl]phenyl]-N’-methoxy IUPAC name: 1-(4-{1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl}phenyl)-3-methoxyurea
    D.3.9.4EV Substance CodeSUB168257
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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.2.5The 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 name1 mg estradiol / 0.5 mg norethindrone acetate
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNorethisterone Acetate
    D.3.9.1CAS number 51-98-9
    D.3.9.3Other descriptive nameNORETHINDRONE ACETATE
    D.3.9.4EV Substance CodeSUB03457MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESTRADIOL HEMIHYDRATE
    D.3.9.1CAS number 50-28-2
    D.3.9.3Other descriptive nameESTRADIOL
    D.3.9.4EV Substance CodeSUB11941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    heavy menstrual bleeding associated with uterine fibroids
    E.1.1.1Medical condition in easily understood language
    heavy menstrual bleeding associated with fibroids in 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 LLT
    E.1.2Classification code 10027331
    E.1.2Term Menstrual flow altered
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10046783
    E.1.2Term Uterine fibroid
    E.1.2System Organ Class 100000004864
    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 long-term efficacy of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002), on heavy menstrual bleeding associated with uterine fibroids.
    E.2.2Secondary objectives of the trial
    To evaluate long-term efficacy of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, among patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002), on the following:
    o Achievement/maintenance of amenorrhea;
    o Hemoglobin;
    o Changes in symptom severity and quality of life related to uterine fibroids as measured by the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL);
    o Impact of heavy menstrual bleeding on social, leisure, and physical activities as measured by the Menorrhagia Impact Questionnaire (MIQ);
    o Uterine volume;
    o Uterine fibroid volume.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Completed 24 weeks of study drug treatment and study participation in either MVT-601-3001 orMVT-601-3002;
    2.Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures for MVT-601-3003;
    3.Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids withinthe study period, including during the Safety Follow-Up period;
    4.Has a negative urine pregnancy test at the Week 24/Baseline visit;
    5.Agrees to continue to use acceptable nonhormonal contraceptive methods as described in Section 4.6 consistently during the Open-Label Treatment period and for at least 30 days after the last dose of study drug. However, the patient is not required to use the specified nonhormonalcontraceptive methods if she:
    a.Has a sexual partner(s) who was vasectomized at least 6 months prior to the Week 24/Baseline visit;
    b.Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 4 months prior to the Week 24/Baseline visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram) and there must be no evidence ofpost-Essure syndrome;
    c.Has a nonhormonal intrauterine device (eg, Paragard®) placed in the uterus;
    d.Is not sexually active with men; periodic sexual relationship(s) with men requires the use of nonhormonal contraception as noted above;
    e.Practices total abstinence from sexual intercourse, as her preferred lifestyle; periodic abstinence is not acceptable.
    E.4Principal exclusion criteria
    1.Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVT-601-3001 or MVT-601-3002);
    2.Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur (eg, bilateral hip replacement, spinal hardware in the lumbar spine);
    3.Has a Z-score < -2.0 or has a ≥ 7% decrease in bone mineral density from the parent study Baseline at lumbar spine, total hip, or femoral neck based on the parent study Week 24 DXA assessment of bone mineral density;
    4.Anticipated to use any prohibited medications as detailed in Section 5.9.1;
    5.Has any contraindication to treatment with low-dose estradiol and norethindrone acetate, including:
    a.Known, suspected, or history of breast cancer;
    b.Known or suspected estrogen-dependent neoplasia;
    c.Active deep vein thrombosis or pulmonary embolism, or history of these conditions prior to the Week 24/Baseline visit;
    d.History of or active arterial thromboembolic disease, including stroke and myocardial infarction;
    e.Known anaphylactic reaction or angioedema or hypersensitivity to estradiol or norethindroneacetate;
    f.Known protein C, protein S, or antithrombin deficiency, or other known thrombophiliadisorders, including Factor V Leiden;
    g.Migraine with aura;
    h.History of porphyria;
    6.Has current active liver disease from any cause;
    7.Has a systemic autoimmune disease (eg, systemic lupus erythematosus, Sjogren’s syndrome, rheumatoid arthritis, polymyositis, systemic sclerosis, psoriasis, psoriatic arthritis, vasculitic syndromes, etc). Psoriasis not requiring or anticipated to require systemic therapy is permitted;
    8.Had any of the following clinical laboratory abnormalities at the parent study Week 20 visit or any subsequent visit in one of the parent studies (MVT-601-3001 or MVT-601-3002):
    a.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (ULN); or
    b.Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome);
    9.Is currently pregnant or lactating, or intends to become pregnant during the study period or within1 month after the last dose of study drug, or plans to donate ova during the study period or within2 months after the last dose of study drug;
    10.Has a decline in presenting visual acuity score as defined below (unless explained by refractive error or approved by the Sponsor):
    a.90 or lower and 5 or more points lower at Week 24/Baseline visit relative to the parent study Baseline visit; OR
    b.The presenting visual acuity score has decreased by 10 or more points at the Week 24/Baseline visit relative to the parent study Baseline visit;
    Note: visual acuity score must have been obtained with corrective lenses, if applicable;
    11. Is inappropriate for participation in this study because of conditions that may interfere with interpretation of study results or prevent the patient from complying with study requirements, as determined by the investigator, sub-investigator, or medical monitor.
    12. Met a withdrawal criterion in the parent study (MVT-601-3001 or MVT-601-3002).
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion of women who achieve or maintain a menstrual blood loss volume of < 80 mL AND at least a 50% reduction from parent study Baseline to the last 35 days of treatment, as measured by the alkaline hematin method.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from parent study Baseline to the last 35 days of treatment
    E.5.2Secondary end point(s)
    •Time to achieve a menstrual blood loss volume of < 80 mL AND at least a 50% reduction from parent study Baseline menstrual blood loss volume as measured by the alkaline hematin method;
    •Change from parent study Baseline to Week 52 in menstrual blood loss;
    •Proportion of women who achieve or maintain amenorrhea over the last 35 days of treatment;
    •Proportion of women with a hemoglobin below the lower limit of normal at parent study Baseline who achieve an increase of ≥ 1 g/dL from parent study Baseline at Week 52;
    •Proportion of women with a hemoglobin below the lower limit of normal at parent study Baseline who achieve a normal hemoglobin at Week 52;
    •Change from parent study Baseline to Week 52 in hemoglobin;
    •Change from parent study Baseline to Week 52 in the Uterine Fibroid Scale – Symptom Severity;
    •Change from parent study Baseline to Week 52 in the Uterine Fibroid Scale – Health-related Quality of Life subscales and total score;
    •Change from parent study Baseline to Week 52 in the MIQ score for physical activities;
    •Change from parent study Baseline to Week 52 in the MIQ score for social and leisure activities;
    •Change from parent study Baseline to Week 52 in uterine volume;
    •Change from parent study Baseline to Week 52 in uterine fibroid volume.
    E.5.2.1Timepoint(s) of evaluation of this end point
    from parent study Baseline to Week 52
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Belgium
    Brazil
    Chile
    Czech Republic
    Germany
    Hungary
    Italy
    Poland
    South Africa
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 600
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 600
    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)
    Eligible patients may enter the 52-week randomized withdrawal study (MVT-601-035), which is conducted under a separate protocol.
    Patients will provide separate informed consent to participant for Study MVT-601-035, which will enroll patients who responded to study treatment at the end of this study and randomize them to receive relugolix 40 mg co-administered with 1 mg estradiol and 0.5 mg norethindrone acetate, or placebo.
    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 Decision2018-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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