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    Summary
    EudraCT Number:2004-003829-28
    Sponsor's Protocol Code Number:TAK-013/EC204
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-17
    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 number2004-003829-28
    A.3Full title of the trial
    An open-label investigation into the tolerability and pharmacokinetic / pharmacodynamic effects of sufugolix (TAK-013), at a dosage of 100mg twice-daily, during six months treatment of pre-menopausal women with endometriosis.
    A.4.1Sponsor's protocol code numberTAK-013/EC204
    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) antagonist
    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
    symptomatic 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 establish, through diary recordings of vaginal bleeding, the frequency of patients achieving suppression of menses during the treatment period from Week 8 (inclusive) to Week 24 (end of the treatment with study medication).
    E.2.2Secondary objectives of the trial
    To characterise treatment-related changes in serum E2 levels within the study population during the 24-week study treatment and 4-week follow-up periods.

    To characterise the pharmacokinetics of sufugolix (TAK-013) during the 24-week treatment period - assessed by serial (trough) plasma concentrations of the parent compound within the study population.

    To evaluate the safety profile of sufugolix (TAK-013) over the study duration.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Pre-menopausal females aged between 18 and 45 years inclusive.

    2. New diagnosis of symptomatic endometriosis, or recorded confirmation / re-confirmation by laparoscopy within the 3 years prior to study enrolment. Subjects should have one or more current symptoms comprising dysmenorrhea, pelvic pain, dyspareunia.

    3. Body Mass Index (BMI) <40 kg/m2.

    4. Normal menses - defined as three or more consecutive days of bleeding which requires protection, and a cycle duration of 21 - 35 days for at least two menstrual cycles prior to study screening.

    5. Neither pregnant nor lactating - with negative urine pregnancy tests at study screening and at enrolment (prior to receiving the first dose of study medication).

    6. Acceptable method of contraception during the entire study duration - defined as use of either a condom plus spermicide preparation, condom plus cap (with or without spermicide) or diaphragm plus condom (with or without spermicide);

    [Note Unacceptable contraception methods include: oral contraceptive pills or other hormonal methods, IUDs, natural “rhythm” methods, withdrawal and spermicides, condoms, caps or diaphragms used alone.]

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

    8. Ability to comprehend, and willingness to sign, an Informed Consent Form.

    9. Ability and willingness to undertake all study-related procedures - including the taking of oral medication.
    E.4Principal exclusion criteria
    1. History of any form of cancer (other than adequately treated basal cell and squamous cell cancers of the skin).

    2. Known to be HIV positive, Hepatitis B surface antigen (HBsAg) or Hepatitis C (HCV) positive.

    3. ALT/SGPT >1.5 times ULN, bilirubin >1.5 mg/dL, any hepatic or renal impairment.

    4. Hysterectomy and/or bilateral oophorectomy.

    5. Abnormal menstrual bleeding unrelated to endometriosis.

    6. History of osteoporosis, osteopenia, hypocalcemia or other metabolic bone disease.

    7. Known or documented history of severe allergic or idiosyncratic reactions to any drug – including sufugolix (TAK-013).

    8. Known history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within the 2 years prior to study enrolment.

    9. Use of the following medications in the 3 months prior to study enrolment and throughout the study: GnRH analogues, oral contraceptives, sex hormone medications (including - but not limited to - norethindrone or norethindrone acetate, depomedroxyprogesterone, estrogen preparations, other progestins) and Danazol. Investigators should consider any history or prior use of GnRH analogue therapy in terms of possible bone mineral density loss, and take account of such effects in establishing suitability of subjects for this study. (section 7.10 also lists other concomitant medications prohibited throughout the course of this study.)

    10. A positive pregnancy test.

    11. Less than 3 months post-partum or post-lactation at onset of therapy within this study.

    12. Surgery (other than laparoscopy for endometriosis) planned to occur during the 8 months which follow study screening.

    13. Current participation in any clinical trial (marketed product or otherwise) or within the 30 days prior to the study screening.

    14. Any disease or disease state that, in the opinion of an investigator, would interfere with the study (e.g. chronic depression requiring treatment).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for efficacy will be the frequency of subjects for whom suppression of menses is achieved during the study treatment period from Week 8 (inclusive) to Week 24 (end of the treatment with study medication). The data will be derived from daily vaginal bleeding scores recorded in diaries by the study patients throughout the treatment period.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Information not present in EudraCT
    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 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.8.3 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 2005-02-17. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2004-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-08-31
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