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    Summary
    EudraCT Number:2011-002770-23
    Sponsor's Protocol Code Number:EB91
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-06-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-002770-23
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, proof of concept study to investigate the safety and efficacy of the combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in women with hypoactive sexual desire disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the effect of testosterone and tadalafil on sexual in women with low sexual desire
    A.3.2Name or abbreviated title of the trial where available
    EB91
    A.4.1Sponsor's protocol code numberEB91
    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 SponsorEmotional Brain BV
    B.1.3.4CountryNetherlands
    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 supportEmotional Brain BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEmotional Brain BV
    B.5.2Functional name of contact pointJeroen Gerritsen
    B.5.3 Address:
    B.5.3.1Street AddressLouis Armstrongweg 78
    B.5.3.2Town/ cityAlmere
    B.5.3.3Post code1311 RL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031365468346
    B.5.5Fax number0031365497186
    B.5.6E-mailj.gerritsen@emotionalbrain.nl
    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 Cialis
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lily Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 nametestosterone cyclodextrine
    D.3.2Product code testosterone cyclodextrine
    D.3.4Pharmaceutical form Oromucosal liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    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 Yes
    D.3.11.13.1Other medicinal product typeHormonal product (sex hormone)
    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 placeboOromucosal liquid
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypoactive Sexual Desire Disorder
    E.1.1.1Medical condition in easily understood language
    Problems with sexual desire
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10059272
    E.1.2Term Sexual desire decreased
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10020933
    E.1.2Term Hypoactive sexual desire disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10037228
    E.1.2Term Psychosexual dysfunction with inhibited sexual desire
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10040465
    E.1.2Term Sexual arousal decreased
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with hypoactive sexual desire disorder (HSDD).
    E.2.2Secondary objectives of the trial
    • To investigate the efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing vaginal pulse amplitude (VPA), clitoral blood volume (CBV) and subjective ratings of sexual desire and arousal in the laboratory, in healthy female subjects with hypoactive sexual desire disorder (HSDD).
    • To evaluate the safety of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent
    2. Female 21 to 45 years of age, inclusive, premenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained professional.
    3. Heterosexual orientation
    4. Be involved in a stable relationship
    5. Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
    E.4Principal exclusion criteria
    Cardiovascular Conditions
    1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
    2. History of myocardial infarction, stroke, transient ischemic attack or life threatening arrhythmia within the prior 6 months
    3. Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)
    4. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects > 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 90 mmHg
    5. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg
    Gynecological and Obstetric Conditions
    6. Use of oral contraceptive containing anti androgens
    7. Use of oral contraceptive containing 50 μg estrogen or more
    8. Positive test result for Chlamydia or Gonorrhea
    9. Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women prior to the administration of study medications.)
    10. Lactating or delivery in the previous 6 months
    11. Significant abnormal pap smear in the previous 12 months
    12. History of bilateral oophorectomy
    13. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
    Other Medical Conditions
    14. Liver and/or renal insufficiency (aspartate aminotransferase and alanine aminotransferase > 3 times the upper limit of normal and/or glomerular filtration rate < 29 mL/min based on the Cockcroft and Gault formula)
    15. Current clinically relevant endocrine disease or uncontrolled diabetes mellitus
    16. Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could form a contraindication for tadalafil and/or testosterone use
    17. History of hormone dependent malignancy
    18. Vision impairment, such as partial or complete blindness or color blindness
    19. Dyslexia
    20. Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
    Psychological/Psychiatric Factors
    21. History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered
    22. Treatment for a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for tadalafil and/or testosterone use
    23. Current psychotherapeutic treatment for female sexual dysfunction
    24. Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).
    25. A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study.
    26. Positive test result for illicit drugs
    Concomitant Medications
    27. Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine, saquinavir and grapefruitjuice)
    28. Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St Johns Wort, rifampicin)
    29. Use of nitrates or nitric oxide donor compounds
    30. Use of SSRIs
    31. Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid)
    32. Use of medication (including herbs) that would compromise the validity of study results
    33. Use of testosterone therapy within 6 months before study entry
    General
    34. Illiteracy, unwillingness, or inability to follow study procedures
    35. Participation in other clinical trials within the last 90 days
    36. Any other clinically significant abnormality or condition which, in the opinion of the investigator, might interfere with the participant’s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for tadalafil and/or testosterone use
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the increase in sexual satisfaction of a single coital event, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ), and through a psychological interview discussing in depth (at follow up but whilst still blinded) the difference between two sexual events experienced at home whilst using study medication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following unblinding
    E.5.2Secondary end point(s)
    Physiological sexual response
    o VPA in response to erotic film clips
    o CBV in response to erotic film clips

    Subjective sexual response
    o Subjective rating of sexual desire and arousal in response to an erotic film clip (SARSAQ)

    Safety assessments
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following unblinding
    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 No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 trial1
    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
    Final visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 6
    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 state6
    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
    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 Decision2011-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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