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    Summary
    EudraCT Number:2017-001588-19
    Sponsor's Protocol Code Number:MVT-601-3101
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-04
    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 number2017-001588-19
    A.3Full title of the trial
    SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of Relugolix in Women with Endometriosis-Associated Pain
    A.3.2Name or abbreviated title of the trial where available
    SPIRIT 1
    A.4.1Sponsor's protocol code numberMVT-601-3101
    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 pointLeonid Katz, M.D.Medical Monitor
    B.5.3 Address:
    B.5.3.1Street Address2000 Sierra Point Parkway, 9th Floor
    B.5.3.2Town/ cityBrisbane
    B.5.3.3Post codeCA 94005
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1(650) 238-1837
    B.5.6E-mailleonid.katz@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 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 nameTAK-385
    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.2.1.1.1Trade name Activelle
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameActivelle® (1 mg estradiol / 0.5 mg norethindrone)
    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
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    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
    1.To determine the benefit of relugolix 40 mg once daily co-administered with 24 weeks of low-dose estradiol and norethindrone acetate compared with placebo on dysmenorrhea;
    2.To determine the benefit of relugolix 40 mg once daily co-administered with 24 weeks of low-dose estradiol and norethindrone acetate compared with placebo on non-menstrual pelvic pain (NMPP).
    E.2.2Secondary objectives of the trial
    To determine the benefit of relugolix 40 mg once daily co-administered with 24 weeks of low-dose estradiol and norethindrone acetate compared with placebo on the following:
    o Function measured by the EHP-30 Pain Domain,
    o Dysmenorrhea measured by the NRS; o PGIC for dysmenorrhea;
    o NMPP measured by the NRS;
    o PGIC for NMPP;
    o Dyspareunia measured by the NRS;
    o PGIC for dyspareunia;
    o Dyspareunia-related functional effects (sB&B);
    o Patient Global Assessment (PGA) for pain;
    o PGA for function;
    o Endometriosis-associated quality of life (Control and Powerlessness,Social Support, Emotional Well-Being, and Self-Image domains of the EHP-30);
    o Dysmenorrhea-related functional effects (sB&B);
    o NMPP-related functional effects (sB&B).
    o PGA for dysmenorrhea
    o PGA for NMPP
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomics optional sample collection
    E.3Principal inclusion criteria
    1. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures;
    2. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing date of the informed consent form;
    3. By the patient’s report, had 2 consecutive regular menstrual cycles (ie, 21 to 35 days in duration) immediately prior to Randomization. For patients who have washed off hormonal contraceptives, the 2 regular cycles must start after the first (withdrawal) bleeding following discontinuation of contraceptives;
    4. Has agreed to use only study-specified analgesic medications during the study and is not known to be intolerant to these;
    5. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the informed consent form, surgical or direct visualization and/or histopathologic confirmation of endometriosis, for example, during a laparoscopy or laparotomy;
    6. During the Screening visit, the patient reports moderate, severe, or very severe pain during the most recent menses and for NMPP in the prior month;
    7. During the Run-In Period (Days R1 through 35), has at least 24 days of completed eDiary scores;
    8. During the Run-In Period (Days R1 through R35), has a dysmenorrhea NRS score >= 4.0 on at least 2 days AND
    a. Mean NMPP NRS score > =2.5 OR
    b. Mean NMPP NRS score >= 1.25 AND NMPP NRS score >= 5.0 on >= 4.0 days;
    For patients with fewer than 3 dysmenorrhea scores during Days R1 - R35, dysmenorrhea scores from Days R36 – 70 will be included in the eligibility determination until a total of 3 dysmenorrhea scores from the Run-In Period are available
    9. Has menstruated for at least 3 days during the Run-In Period
    10. Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis (including ablation, shaving, or excision) during the study, including during the Follow-Up Period, and the patient does not desire such treatment during this time frame;
    11. Has a negative urine pregnancy test at the Screening visit and on the Baseline Day 1 visit;
    12. Agrees to use contraception during the study and for 30 days following the last dose of study drug. Specifically, agrees to use nonhormonal contraception as described in Section 4.7 consistently during the Screening Period, Run-In Period, and the Randomized Treatment Period for 30 days. However, the patient is not required to use the specified nonhormonal contraception if she:
    a. Has a sexual partner(s) who was vasectomized at least 6 months prior to the Screening Period;
    b. Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 6 months prior to the Screening visit (patients with Essure must have prior confirmation of tubal occlusion by hysterosalpingogram and no evidence of “post-Essure syndrome” in the investigator’s opinion);
    c. Is not sexually active with men; periodic sexual relationship(s) with men requires the use of nonhormonal contraception as noted above; or
    d. Practices total abstinence from sexual intercourse as her preferred lifestyle. Periodic abstinence is not acceptable
    13. Has an adequate endometrial (aspiration) biopsy performed during the Screening visit with results showing no clinically significant endometrial pathology (hyperplasia, polyp, or endometrial cancer);
    Note 1: Patients for whom polyps are detected on the biopsy but are either not evident on ultrasound or < 2.0 cm by ultrasound are eligible;
    Note 2: endometrial biopsies that were performed or repeated during the Run-In Period and meet criteria are
    acceptable;
    14. If > =39 years of age at the time of the Screening, has a normal mammogram (Breast Imaging Reporting and Data System category 1 to 2 or equivalent; see Appendix 1) during the Run-In Period or within 6 months prior to the Run-In Period.
    E.4Principal exclusion criteria
    1. Has a history of chronic pelvic pain that is not caused by endometriosis
    2. Has had 4 or more prior laparoscopic or open abdominal or pelvic, surgical, or other invasive procedure for endometriosis;
    3. During the Run-In Period, reports NMPP is “much better” on the PGIC for NMPP
    4. Has a transvaginal ultrasound during the Screening visit demonstrating pathology other than endometriosis that could be responsible for or contributing to the patient’s chronic pelvic pain or a clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment during the study
    5. Has any chronic pain or frequently recurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for > 7 days per month
    6. Has a had gynecological surgery or other surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit
    7. Has a history of previous non-response of NMPP or dysmenorrhea to GnRH agonists, GnRH antagonists, depot medroxyprogesterone acetate, or aromatase inhibitors based on patient’s report or treating physician’s assessment of chart documentation;
    8. Has unexplained vaginal bleeding outside of the patient’s regular menstrual period
    9. Has a weight that exceeds the weight limit of the DXA scanner
    10. Has bone mineral density z-score < -2.0 at spine, total hip, or femoral neck during the Run-In Period
    11. Has a gastrointestinal disorder affecting absorption or gastrointestinal motility
    12. Has used, is using or is anticipated to use prohibited medications;
    13. Patients receiving selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, or tricyclic antidepressants that have been recently started or undergone recent dose changes. Patients who have been on stable doses for at least 3 months and are anticipated to remain on stable doses during the study (including the Run-In Period) may be enrolled
    14. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic or atraumatic fracture. A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed
    15. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
    16. Has a systemic autoimmune disease
    17. Has any contraindication to treatment with low-dose estradiol and norethindrone acetate,
    18. Has jaundice or known current active liver disease from any cause including hepatitis A (hepatitis A virus [HAV] immunoglobulin M [IgM]), hepatitis B (hepatitis B virus surface antigen [HBsAg]), or hepatitis C (hepatitis C virus [HCV] antibody [Ab] positive, confirmed by HCV ribonucleic acid [RNA])
    19. On the most recently documented Papanicolaou test, has any of the following cervical pathology: high-grade cervical neoplasia, atypical glandular cells, atypical endocervical cells, or atypical squamous cells favoring high grade. Of note, patients with atypical squamous cells of undetermined significance and low-grade cervical neoplasia may be included in the study if high-risk human papilloma virus testing is negative or if deoxyribonucleic acid (DNA) testing for human papilloma virus 16 and 18 is negative
    20. Has any clinical laboratory abnormalities during the Screening or Run-In Period:
    21. Has clinically significant cardiovascular disease
    22. Has been a participant in an investigational drug or device study within the 1 month prior to the Screening visit
    23. Has a history of clinically significant condition(s)
    24. Is currently pregnant or lactating, or intends to become pregnant or to donate ova during the study period or within 2 months after the last dose of study drug
    25. Has a contraindication or history of sensitivity to any of the study treatments or components thereof, including protocol-specified analgesic medications; or has a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates study participation
    26. Has a prior (within 1 year of the Screening visit) or current history of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders V (all patients must be questioned about their drug and alcohol use)
    27. Has participated in a previous clinical study that included the use of relugolix
    28. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study
    29. 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.
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of responders at the Week 24/EOT pain assessment period, based on their dysmenorrhea Numerical Rating Scale (NRS) scores recorded in a daily electronic diary (eDiary), in the relugolix
    40 mg group co-administered with lowdose hormonal add-back therapy for 24 weeks versus placebo;
    2.Proportion of responders at the Week 24/EOT pain assessment period, based on their NMPP NRS scores recorded in a daily eDiary, in the relugolix 40 mg group co-administered with low-dose hormonal add-back therapy for 24 weeks versus placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    E.5.2Secondary end point(s)
    -secondary endpoints will be assessed comparing Group A with Group C:
    -Change from Baseline at Week 24 in the EHP-30 Pain Domain scores in the relugolix 40 mg group co-administered with low-dose hormonal addback therapy for 24 weeks versus placebo;
    - Change from Baseline to Week 24/EOT in the mean dysmenorrhea NRS score;
    - Change from Baseline to Week 24/EOT in the severity scores on the PGA for dysmenorrhea;
    - Change from Baseline to Week 24/EOT in the mean NMPP NRS score;
    - Proportion of patients who are better or much better on the PGIC for dysmenorrhea at Week 24/EOT;
    - Change from Baseline to Week 24/EOT in the severity scores on the PGA for NMPP;
    - Proportion of patients who are better or much better on the PGIC for NMPP at Week 24/EOT.
    - Change from Baseline to Week 24/EOT in the mean dyspareunia NRS scores.
    - Proportion of patients who are better or much better on the PGIC for dyspareunia at Week 24/EOT;
    - Change from Baseline to Week 24/EOT in the mean dyspareunia functional impairment on the sB&B scale;
    - Change from Baseline to Week 24/EOT in severity scores on the PGA for pain;
    - Change from Baseline to Week 24/EOT in function impairment on the PGA for function;
    -Proportion of responders at Week 24/EOT based on their EHP-30 Pain Domain score;
    - Change from Baseline to Week 24/EOT in each of the non-pain EHP-30 domains (Control and Powerlessness, Social Support, Emotional Well- Being, and Self-Image);
    - Change from Baseline to Week 24/EOT in the mean dysmenorrhea functional impairment on the sB&B scale;
    - Change from Baseline to Week 24/EOT in the mean NMPP functional impairment on the sB&B scale.
    -The following secondary endpoints will be assessed comparing Group B with Group C:
    - Proportion of responders at the Week 24/EOT pain assessment period, based on their dysmenorrhea NRS scores recorded in a daily eDiary;
    - Proportion of responders at the Week 24/EOT pain assessment period, based on their NMPP NRS scores recorded in a daily eDiary.
    - Change from Baseline at Week 24/EOT in the EHP-30 Pain Domain scores.
    -Proportion of responders at Week 24/EOT based on their EHP-30 Pain Domain score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 24
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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
    Argentina
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Finland
    Hungary
    Poland
    Portugal
    South Africa
    Spain
    Ukraine
    E.8.7Trial has a data monitoring committee Yes
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 329
    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, including women randomized to placebo, will be offered the opportunity to enroll in a 28-week open-label extension study where patients will receive relugolix co-administered with low-dose estradiol and norethindrone acetate. Patients who do not enroll into the extension study will have a Follow-Up visit approximately 30 days after the patient’s last dose of study drug.
    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 Decision2017-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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