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    Summary
    EudraCT Number:2012-000870-51
    Sponsor's Protocol Code Number:CMCS240281
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000870-51
    A.3Full title of the trial
    RANDOMIZED CLINICAL TRIAL TO ASSESS THE EFFICACY OF TESTOSTERONE UNDECANOATE, METFORMIN, OR THE COMBINATION OF BOTH, FOR THE TREATMENT OF ISOLATED HYPOGONADOTROPIC HYPOGONADISM AND ERECTILE DYSFUNCTION IN OBESE MALES
    ESTUDIO ALEATORIZADO PARA EVALUAR LA EFICACIA DE UNDECANOATO DE TESTOSTERONA, METFORMINA, O LA COMBINACIÓN DE AMBOS, COMO TRATAMIENTO DEL HIPOGONADISMO HIPOGONADOTROPO AISLADO Y LA DISFUNCIÓN ERÉCTIL EN VARONES OBESOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evalation of the effects of testosterone undecanoate, metformin, or a combination of both, for the treatment of decreased testicular function and erectile dysfunction in obese males
    Evaluar el efecto de undecanoato de testosterona, metformina, o la combinación de ambos para el tratamiento de la función testicular disminuida y la disfunción eréctil en varones con obesidad
    A.4.1Sponsor's protocol code numberCMCS240281
    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 SponsorUnidad de Gestión Clínica de Endocrinología y Nutrición
    B.1.3.4CountrySpain
    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 supportBayer AG
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Gestión Clínica de Endocrinología y Nutrición
    B.5.2Functional name of contact pointUGC Endocrinologia y Nutrición
    B.5.3 Address:
    B.5.3.1Street AddressCampus de Teatinos s/n
    B.5.3.2Town/ cityMalaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number34951034016
    B.5.5Fax number34951924651
    B.5.6E-mailjosecarlosfdezgarcia@hotmail.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 Yes
    D.2.1.1.1Trade name Dianben 850 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck-Serono
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDianben
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 Reandron
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Injection
    D.3.4.1Specific paediatric formulation No
    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 INNTestosterone Undecanoate
    D.3.9.2Current sponsor codeSHL00123B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboFilm-coated tablet
    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 placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Isolated hypogonadotropic hypogonadism related to obesity
    Hipogonadismo hipogonadotropo aislado asociado a obesidad
    E.1.1.1Medical condition in easily understood language
    Obese males with decreased testicular function
    Varones obesos con función testicular disminuida
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    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 of testosterone undecanoate, metformin, or the combination of both, for the treatment of isolated hypogonadotropic hypogonadism and erectile dysfunction in obese males.
    The main outcome is:
    - Changes in IIEF (International Index of Erectile Disfunction) score after 52 weeks of treatment.
    Evaluar la eficacia del tratamiento con undecanoato de testosterona, metformina, o la combinación de ambos, en el tratamiento del hipogonadismo hipoganodotropo aislado y la disfunción eréctil en varones obesos.
    El objetivo principal del presente trabajo es estudiar:
    - Cambios en la escala IIEF (Índice Internacional de Disfunción Eréctil) a las 52 semanas del inicio del tratamiento
    E.2.2Secondary objectives of the trial
    Secondary outcomes are:
    -Changes in AMS (Aging Males Symptoms) score after 52 weeks of treatment.
    - Cahnges in ADAM (Androgen Deficiency in the Aging Male) after 52 weeks of treatment.
    - Changes in the concentrations of total testosterone and free testosterone after 52 weeks of treatment.
    - Changes in BMI after 52 weeks of treatment.
    - Changes in concentrations of fat mass and lean mass (measured by multifrequency bioelectrical impedance electrical) after 52 weeks of treatment.
    - Changes in the levels of insulin and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) after 52 weeks of treatment.
    Los objetivos secundarios del presente trabajo son:
    - Cambios en la escala AMS (Aging Males Symptoms) tras 52 semanas de tratamiento.
    - Cambios en la escala ADAM (Androgen Deficiency in the Aging Male) tras 52 semanas de tratamiento.
    - Cambios en las concentraciones de testosterona total y testosterona libre tras 52 semanas de tratamiento.
    - Cambios en el IMC tras 52 semanas de tratamiento.
    - Cambios en las concentraciones de masa grasa y masa magra (medido por bioimpedanciometría eléctrica multifrecuencia) tras 52 semanas de tratamiento.
    - Cambios en los niveles de insulina y HOMAIR (Homeostatic model assessment of Insulin Resistence) tras 52 semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men aged 18 to 65 years.
    2. BMI ? 30 kg/m2.
    3. Total testosterone levels <3.5 ng/dl.
    4. LH levels <7.7 mIU / ml.
    6. No evidence of any other pituitary hormone disruption in morning blood sample (normal concentrations of TSH, FT4, Prolactin, ACTH, cortisol and IGF-1
    7. Being able to provide informed consent before randomization and agree to comply with all the procedures included in the protocol.
    1. Varones con edad entre 18 y 65 años.
    2. IMC ? 30 kg/m2.
    3. Niveles de testosterona total < 3.5 ng/dl.
    4. Niveles de LH < 7.7 mUI/ml.
    5. No encontrar ninguna otra alteración hormonal hipofisaria en muestra sanguínea matutina (niveles normales de TSH, T4l, Prolactina, ACTH, cortisol e IGF-1)
    6. Ser capaz de proporcionar un consentimiento informado antes de la aleatorización y estar de acuerdo en cumplir todos los procedimientos incluidos en el protocolo.
    E.4Principal exclusion criteria
    1. Intolerance/allergy to metformin or testosterone undecanoate.
    2. Previous diagnosis of diabetes mellitus (HbA1c> 6.5% or fasting glucose> 126 mg/dl or glucose> 200 mg/dl after an oral glucose tolerance test)
    3. Treatment with oral hypoglycemic agents, insulin or GLP-1 analogs.
    4. Poor kidney function: serum creatinine> 2.0 mg / dl.
    5. Previous history of prostate cancer or breast cancer.
    6. Active cancer of any kind.
    7. History of liver tumor or acute or chronic liver disease with impaired liver function: total bilirubin> 2.0 mg / dl or GOT levels three times the upper limit of normal.
    8. Central hypogonadism of organic cause
    9. Use in the past 12 months of any drug that affects the pituitary-gonadal axis.
    10. Use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry.
    11. Uncontrolled hypertension (SBP> 160 mmHg or DBP> 100 mmHg) despite adequate antihypertensive therapy.
    12. HIV infection or known active infection with HBV or HCV.
    13. Thrombotic or embolic disease.
    14. Heart disease, kidney or liver disease.
    15. Epilepsy or migraine not adequately controlled with treatment.
    16. Hematocrit> 50% in the screening.
    17. PSA> 4 ng / ml.
    18. Severe benign prostatic hypertrophy with an IPSS scale score over 19.
    19. Evidence of drug or alcohol abuse (> 50 g alcohol / day)
    20. Hematological diseases that produce increased risk of bleeding after intramuscular injection.
    21. Serious underlying disease that might affect the patient's ability to participate in the study (eg ongoing infection, gastric ulcers, active autoimmune disease).
    22. Reduced life expectancy (<12 months) by the presence of comorbidities or advanced terminals.
    23. Participation in another clinical trial within 30 days before study entry.
    24. Previous diagnosis of hemochromatosis
    1. Intolerancia/Alergia a metformina o al undecanoato de testosterona.
    2. Diagnóstico previo de diabetes mellitus (HbA1c > 6.5 % o glucemia basal > 126 mg/dl o glucemia tras 2 horas de sobrecarga oral de glucosa > 200 mg/dl)
    3. Tratamiento con hipoglucemiantes orales, insulina o análogos de GLP-1.
    4. Función renal deficiente: niveles de creatinina sérica > 2.0 mg/dl.
    5. Historia previa de cáncer de próstata o de mama.
    6. Cáncer activo de cualquier tipo.
    7. Historia de tumor hepático o enfermedades hepáticas agudas o crónicas con alteración de la función hepática: niveles de bilirrubina total > 2.0 mg/dl o niveles de GOT tres veces superior al límite superior normal.
    8. Hipogonadismo central de causa orgánica
    9. Uso en los últimos 12 meses de cualquier fármaco que afecte el eje hipofiso-gonadal.
    10. Uso de testosterona oral, bucal o transdermal en las 2 últimas semanas previo a la entrada del estudio, o cualquier éster de testosterona en las últimas 6 semanas o inyección de Undecanoato de testosterona en los 6 meses previos a la entrada en el estudio.
    11. HTA descontrolada (TAS > 160 mmHg o TAD > 100 mmHg) a pesar de una adecuada terapia antihipertensiva.
    12. Infección conocida por VIH o infección activa por VHB o VHC.
    13. Enfermedad trombótica o embólica.
    14. Enfermedad cardíaca, renal o hepática severa.
    15. Epilepsia o migraña no adecuadamente controlada con el tratamiento.
    16. Hematocrito > 50% en el screening.
    17. PSA > 4 ng/ml.
    18. Hipertrofia benigna de próstata severa con una puntuación de la escala IPSS mayor de 19.
    19. Evidencia de abuso de drogas o alcohol (> 50 gramos alcohol/día)
    20. Enfermedades hematológicas que produzcan aumento del riesgo de sangrado tras inyección intramuscular.
    21. Enfermedades subyacentes graves, que podrían afectar a la capacidad del paciente para participar en el estudio (por ejemplo, infección en curso, úlceras gástricas, enfermedad autoinmune activa).
    22. Expectativa de vida reducida (< 12 meses) por presencia de enfermedades concomitantes avanzadas o terminales.
    23. Participación en otro ensayo clínico en un plazo de 30 días antes de la entrada en el estudio.
    24. Diagnóstico previo de hemocromatosis
    E.5 End points
    E.5.1Primary end point(s)
    - Changes in the IIEF (International Index of Erectile Function) score after 52 weeks of treatment.
    - Cambios en la escala IIEF (Índice Internacional de Disfunción Eréctil) tras 52 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    E.5.2Secondary end point(s)
    - Changes in the AMS (Aging Males Symptoms) score after 52 weeks of treatment.
    - Changes in the ADAM (Androgen Deficiency in the Aging Male) score after 52 weeks of treatment.
    - Changes in the concentrations of total testosterone and free testosterone after 52 weeks of treatment.
    - Changes in BMI after 52 weeks of treatment.
    - Changes in concentrations of fat mass and lean mass (measured by multifrequency bioelectrical impedance electrical) after 52 weeks of treatment.
    - Changes in the levels of insulin and HOMA-IR (Homeostatic Model Assessment of Insulin Resistence) after 52 weeks of treatment.
    - Cambios en la escala AMS (Aging Males Symptoms) tras 52 semanas de tratamiento.
    - Cambios en la escala ADAM (Androgen Deficiency in the Aging Male) tras 52 semanas de tratamiento.
    - Cambios en las concentraciones de testosterona total y testosterona libre tras 52 semanas de tratamiento.
    - Cambios en el IMC tras 52 semanas de tratamiento.
    - Cambios en las concentraciones de masa grasa y masa magra (medido por bioimpedanciometría eléctrica multifrecuencia) tras 52 semanas de tratamiento.
    - Cambios en los niveles de insulina y HOMAIR (Homeostatic model assessment of Insulin Resistence) tras 52 semanas de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Last evalution will be at week 52, with a subsequent visit after 12 weeks
    La visita final será a las 52 semanas, con una visita posterior a las 12 semanas
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months0
    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: 72
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state72
    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)
    None
    Ninguno
    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 Decision2013-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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