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    The EU Clinical Trials Register currently displays   36784   clinical trials with a EudraCT protocol, of which   6075   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-001720-21
    Sponsor's Protocol Code Number:TAK-013/EC301
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-07-13
    Trial results View 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 number2004-001720-21
    A.3Full title of the trial
    A Phase III, multi-center, randomized, double-blind comparator study to evaluate the efficacy and safety of 50 mg and 100 mg of TAK-013 tablets administered twice daily versus 3.75mg of Leuprolide administered monthly for 24 weeks in subjects with symptomatic endometriosis.
    A.4.1Sponsor's protocol code numberTAK-013/EC301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Europe R&D Centre Ltd
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameSufugolix
    D.3.2Product code TAK-013
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSufugolix
    D.3.9.2Current sponsor codeTAK-013
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number97.5 to 101
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeGonadotropin-releasing hormone (GnRH) agonist
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Leuprorelin acetate
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharmaceutical Company
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameLeuprorelin acetate
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLeuprorelin Acetate
    D.3.9.1CAS number 53714-56-0
    D.3.9.2Current sponsor codeTAP-144
    D.3.9.3Other descriptive name5-oxo-L-prolyl-L-histidyl-Ltryptophyl-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Endometriosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level LLT
    E.1.2Classification code 10014778
    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 efficacy and safety of 50 mg and 100 mg of sufugolix (TAK-013) administered orally twice daily compared to 3.75 mg of Leuprolide administered monthly in pre-menopausal subjects with symptomatic endometriosis (on symptoms of dysmenorrhea and pelvic pain) for a period of 24 weeks.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of sufugolix (TAK-013) versus Leuprolide on dyspareunia; to assess the effect of sufugolix (TAK-013) on serum levels of Estradiol, Progesterone, LH and FSH over the 24 week dosing period; to evaluate the effects of sufugolix (TAK-013) versus Leuprolide on endometriosis-related quality of life parameters; to assess the duration of post-treatment pain suppression at follow-up.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The subject is a pre-menopausal female and must be 18 to 45 years of age, inclusive.

    2. Female subjects of childbearing potential must be non-pregnant and non-lactating. In addition to a negative human chorionic gonadotropin (HCG) pregnancy test at Screening, they must also have a negative urine HCG pregnancy test result on the day of randomization (Day 0), prior to receiving any dose of study medication.
    From screening until Visit 12, subjects of child bearing potential (e.g. non-sterilized) who are sexually active, must use adequate contraception, unless the sexual partner has undergone vasectomy with proven azoospermia. All subjects will be asked to confirm that they understand the requirements for avoidance of pregnancy during the course of the study as part of the informed consent process. During the course of the study females of child-bearing potential will receive continued advice on avoidance of pregnancies as part of the study procedures.

    The acceptable method for this study is double-barrier contraception. Accepted barrier contraceptive devices include; male condom, female condom, diaphragm, and cap. Double barrier contraception is defined as two different barrier devices used simultaneously, each time the subject has intercourse.

    Note: contraception methods, which are not accepted include: oral contraceptive pills, natural “rhythm” methods, withdrawal and spermicides (used alone).

    3. Endometriosis diagnosis has been laparoscopically or laparotomy confirmed, or has been re-confirmed in the last 3 years prior to study screening.

    4. The subject has symptomatic endometrosis within 1 month prior to screening. A subject is considered to be symptomatic if BOTH of the dysmenorrhea and pelvic pain symptoms are present, one of which is at least moderate, as described in the Biberoglu and Behrman Pain Grading Scale, see Table 2.

    5. The subject must have normal menses for at least 2 cycles prior to screening and a cycle duration of 21-35 days.

    6. If the subject has had surgical reduction of their endometriosis, they must have recurrence of dysmenorrhea and pelvic pain for at least 3 months post-surgery, which in the investigator’s opinion is due to their endometriosis.

    7. With the exception of endometriosis, the subject is otherwise in good health, with no clinically relevant hepatic, renal, cardiovascular, endocrine, metabolic, psychiatric, neurologic, hematologic disease, or any other significant illness or clinical condition.

    8. The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications.

    9. The subject has given written informed consent.
    E.4Principal exclusion criteria
    1. The subject has clinically significant cardiovascular disease that would preclude them from participating in the study (e.g., myocardial infarction or unstable angina).

    2. The subject has a history of any form of cancer (other than adequately treated basal cell and squamous cell cancers of the skin).

    3. The subject has been treated with the following medications within 3 months prior to the administration of the first dose of study medication: Depo-Provera; medications significantly affecting bone metabolism such as raloxifene, calcitonin and bisphosphonates. The investigator should consider any history of prior GnRH analogue therapy with respect to possible bone mineral density loss to assess subject suitability for entry into the study.

    4. The subject has been treated with the following medications within 3 months prior to Screening: oral contraceptives; sex hormone medications such as norethindrone or estrogen preparations and Danazol.

    5. The subject has a positive pregnancy test.

    6. The subject is less than 3 months postpartum or post-lactation at the time of the first dose of study medication.

    7. The subject has a known hypersensitivity to sufugolix (TAK-013) or Leuprolide.

    8. The subject has abnormal menstrual bleeding unrelated to endometriosis.

    9. The subject has a body mass index (BMI) > 40 kg/m2.

    10. The subject has a known history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as routine consumption of more than 4 alcoholic drinks per day) within the past 2 years prior to study entry.

    11. The subject is currently participating in any clinical trial (marketed product or otherwise) or has done so within 30 days prior to the screening visit.

    12. The subject is known to be HIV positive, Hepatitis B surface antigen (HBsAg) or Hepatitis C (HCV) positive.

    13. The subject has a known ALT/SGPT and/or AST/SGOT of >1.5 times ULN, a known bilirubin >1.5 mg/dL, or has any hepatic or renal impairment.

    14. The subject has any disease or disease state that in the opinion of the investigator would interfere with the study (e.g., chronic depression that requires treatment).
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy endpoints will be the symptomatic improvement rate in dysmenorrhea and pelvic pain symptoms since the subject’s last visit compared to baseline by recall using a modified Biberoglu and Behrman Pain Grading Scale during monthly visits and at Week 24.

    The most important secondary efficacy endpoint is symptomatic improvement rate in symptomatic dyspareunia as defined above. Other secondary endpoints include subject provided Global Assessment; time to onset of pain relief; post-treatment pain suppression; vaginal bleeding record and post-treatment return to menses.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    multicentred
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    24 weeks of treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-07-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 200
    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 Decision2004-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-24
    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
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