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    Summary
    EudraCT Number:2010-021790-37
    Sponsor's Protocol Code Number:UK_S-H_08_0006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-10
    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 number2010-021790-37
    A.3Full title of the trial
    Comparison of clinical and metabolic effects of testosterone and estradiol in adult gonadectomized patients with 46,XY DSD due to complete androgen insensitivity syndrome (CAIS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of clinical and metabolic effects of testosterone and estradiol in adult gonadectomized patients with normal male chromosome set and Disorder of Sex Developement due to complete androgen insensitivity syndrome (CAIS)
    A.3.2Name or abbreviated title of the trial where available
    CAIS
    A.4.1Sponsor's protocol code numberUK_S-H_08_0006
    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 SponsorUniversitätsklinikum Schleswig-Holstein, Campus Lübeck
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGerman Federal Ministry of Education and Resarch
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin
    B.5.2Functional name of contact pointStudy coordination
    B.5.3 Address:
    B.5.3.1Street AddressRatzeburger Allee 160
    B.5.3.2Town/ cityLübeck
    B.5.3.3Post code23538
    B.5.3.4CountryGermany
    B.5.4Telephone number+4904515005134
    B.5.5Fax number+4904515005967
    B.5.6E-mailcais_studie@paedia.ukl.mu-luebeck.de
    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 Yes
    D.2.1.1.1Trade name Gynokadin® Dosiergel
    D.2.1.1.2Name of the Marketing Authorisation holderFirma Dr. Kade/Besins Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 50-28-2
    D.3.9.3Other descriptive nameESTRADIOL HEMIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.62
    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 TESTOGEL® 50 mg, Gel im Beutel
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires BESINS INTERNATIONAL
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number 58-22-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboGel
    D.8.4Route of administration of the placeboTransdermal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical condition under investigation is complete androgen insensitivity syndrome (CAIS) in gonadectomized patients with 46,XY karyotype due to mutations of the androgen receptor, which lead to loss of function of androgens.
    E.1.1.1Medical condition in easily understood language
    Complete androgen insensitivity syndrome (CAIS) in gonadectomized patients with normale male chromosome set due to mutations of the androgen receptor and subsequent to loss of function of androgens.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10056292
    E.1.2Term Androgen insensitivity syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Detection of differences in the effects of testosterone versus estradiol treatment on general quality of life measured by psychological sum scale of the SF-36 questionnaire
    E.2.2Secondary objectives of the trial
    Comparison of levels and excretion products of testosterone, estradiol and other metabolites of sexual hormones
    Analysis of effects of different levels of hormones on the levels of SHBG, LH, FSH, Insulin, Glucose, Cholesterol (total, HDL, LDL), Triglycerides, Hematocrit and Hemoglobin
    Detection of differences in the effects of testosterone versus estradiol treatment on general and sexual quality of life
    Analysis of residual androgen receptor activity and correlation between residual activity and effects of testosteron
    Comparison of the incidence of adverse events between both treatments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Postpubertal adult patients (age >= 18 and <= 55 years) with complete androgen insensitivity syndrome with 46, XY karyotype classified as either Sinnecker Type 5A or 5B
    Mutation of the androgen receptor gene proved
    Gonadectomy at least 1 year before entering the study
    Informed consent to participate in the study
    E.4Principal exclusion criteria
    Disorder of sex developement other than complete androgen insensitivity syndrome
    Steroid medication other than study medication (exception: steroids for inhalation, short-term administration of other steroids)
    Gonads in situ
    Disorder of liver function
    Chronic skin disease with influence on resorption of the gels
    Serious chronic disorders affected by sex steroid medication
    Malignant disorders (exception: cured malignant disorders which are not dependent on hormones)
    Severe psychiatric disorder
    Porphyria
    Previous idiopathic or present venous thrombotic or embolic events
    Present or recent arterial thrombotic or embolic events (e.g. myocardial infarction or angina pectoris)
    Allergy to study medication or excipients in study medication
    Clinical trial therapy outside of this trial during or within 4 weeks of study treatment
    E.5 End points
    E.5.1Primary end point(s)
    Quality of life as measured by the psychlogical sum scale of the SF-36 questionnaire
    E.5.1.1Timepoint(s) of evaluation of this end point
    At months 0, 2 (start of study medication 1), 5, 8 (end of study medication 1 and start of study medication 2), 11, 14 (end of study medikation 2) and 17 (end of study).
    E.5.2Secondary end point(s)
    Quality of life as measured by the physical sum scale of the SF-36 questionnaire
    Psychological well-being assessed by the questionnaire Brief Symptom Inventory
    Sexual quality of life as measured by the questionnaire FSFI-d
    Hormone levels in serum and urine, SHBG, LH, FSH, Insulin, Glucose, Cholesterol (total, HDL, LDL), Triglycerides, Hematocrit and Hemoglobin
    Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    At months 0, 2 (start of study medication 1), 5, 8 (end of study medication 1 and start of study medication 2), 11, 14 (end of study medikation 2) and 17 (end of study).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double dummy
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States No
    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 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 years1
    E.8.9.1In the Member State concerned months11
    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 months11
    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: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    Normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Network DSD / Intersexuality
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-16
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