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    Summary
    EudraCT Number:2012-003543-30
    Sponsor's Protocol Code Number:EB93
    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:2012-08-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-003543-30
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, proof of concept study to investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in women with hypoactive sexual desire disorder
    Een dubbel blind, gerandomiseerd, placebo gecontroleerde, 'proof of concept' onderzoek naar de verschillen tussen de gecombineerde toediening van 0.5mg sublinguale testosteron & 10mg buspiron en toediening van 10mg buspiron alleen, bij vrouwen met 'hypoactive sexual desire disorder'
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the subjective and fysiological effects of the combined administration of testosterone and buspirone and buspirone administration alone in women with decreased sexual desire
    Een studie naar de subjectieve en fysiologische effectiviteit en de veiligheid van de combinatie van testosteron & buspiron en buspiron alleen bij vrouwen met een stoornis in het seksueel verlangen
    A.3.2Name or abbreviated title of the trial where available
    EB93 PoC
    EB93 PoC
    A.4.1Sponsor's protocol code numberEB93
    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 pointClinical Trial Manager J. Gerritsen
    B.5.3 Address:
    B.5.3.1Street AddressLouis Armstrongweg 78
    B.5.3.2Town/ cityAlmere
    B.5.3.3Post code1319EC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310365468346
    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 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 nameBuspirone
    D.3.2Product code Buspirone
    D.3.4Pharmaceutical form 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 INNBUSPIRONE
    D.3.9.1CAS number 36505-84-7
    D.3.9.4EV Substance CodeSUB05992MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE
    D.3.9.1CAS number 55-22-0
    D.3.9.3Other descriptive nameTestosterone cyclodextrine
    D.3.9.4EV Substance CodeSUB10937MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 steroid)
    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 placeboTablet
    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
    Sexual Interest/Arousal Disorder
    Stoornis in het seksueel verlangen (HSDD)
    Stoornis in seksuele interesse en opwinding (SIAD)
    E.1.1.1Medical condition in easily understood language
    Decreased (low or absent) sexual desire (possibly in combination with decreased sexual arousal)
    Verminderd (laag of afwezig) seksueel verlangen (mogelijk in combinatie met verminderd seksuele opwinding)
    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 14.1
    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 14.1
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10040465
    E.1.2Term Sexual arousal decreased
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10058929
    E.1.2Term Disturbance in sexual arousal
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10040470
    E.1.2Term Sexual desire disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10040466
    E.1.2Term Sexual arousal disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10062641
    E.1.2Term Female sexual arousal disorder
    E.1.2System Organ Class 10038604 - Reproductive system and breast 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 differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with hypoactive sexual desire disorder (HSDD).
    Het verschil onderzoeken tussen de gecombineerde toediening van 0,5 mg sublinguaal testosteron en 10 mg buspiron en 10 mg buspiron administratie alleen voor het verhogen van seksuele tevredenheid tijdens seksuele activiteit in de huiselijke sfeer bij gezonde vrouwelijke proefpersonen met een stoornis in het seksueel verlangen (HSDD)
    E.2.2Secondary objectives of the trial
    To investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone 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).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent.
    2. Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed). The diagnosis will be made by an experienced psychologist/sexologist.
    3. Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically irrelevant.
    4. Subjects must have a heterosexual relationship.
    5. Be involved in a stable relationship and have a partner who will be accessible during the 3-week at home period.

    E.4Principal exclusion criteria
    Cardiovascular conditions
    1. Any underlying cardiovascular condition, including unstable angina pectoris
    2. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
    3. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg

    Gynecological and obstetric conditions
    4. Use of oral contraceptive containing anti-androgens (e.g. Crypteron acetate) or (anti)androgenic progestogens (drospirone, dienogest, chlormadinone acetate and norgestrel)
    5. Use of oral contraceptive containing 50 μg estrogen or more
    6. Pregnancy or intention to become pregnant during this study (Note: An urine pregnancy test will be performed in all women prior to the administration of study medications.)
    7. Lactating or delivery in the previous 6 months
    8. Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
    9. Subjects with a perimenopausal hormonal status (follicle-stimulating hormone>40)

    Other medical conditions
    10. Liver- and/or renal insufficiency
    11. Current clinically relevant endocrine disease
    12. Current clinically relevant neurological disease which, in the opinion of investigator, would compromise the validity of study results, or which could form a contraindication for buspirone and/or testosterone use
    13. (A history of) hormone-dependant malignancy
    14. Vision impairment, such as partial or complete blindness or color blindness
    15. Dyslexia
    16. Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)

    Psychological/psychiatric factors
    17. History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
    18. (Psychotherapeutic and/or pharmacological 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 buspirone and/or testosterone use
    19. Current psychotherapeutic treatment for female sexual dysfunction
    20. Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision (DSM IV TR))
    21. 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 (mild or moderate alcohol consumption is allowed but must be stopped 12 hours before the Stroop task).
    22. Positive test result for illicit drugs

    Concomitant medication
    23. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir)
    24. Subjects who are taking CYP3A4-inducers (eg, carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine)
    25. Use of serotonergic drugs (eg, trazodon, fluvoxamine), tricyclic antidepressants or other antidepressants
    26. Use of testosterone therapy within 6 months before study entry
    27. Use of any other medication that interferes with study medication (eg, monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (eg, diltiazem and verapamil), triptans)

    General
    28. Illiteracy, unwillingness, or inability to follow study procedures
    29. Any other clinically significant abnormality or condition which, in the opinion of 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 buspirone and/or testosterone use.
    30. Participation in any other clinical drug study in the previous 3 months.
    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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 measurements at home within a 3-week period
    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 (as defined in Section 4.3.4.2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 psychophysiological measurements in the laboratory within a 2-week 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 trial3
    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 subject's end-of-study/follow up visit
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months2
    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: 9
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.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 Decision2012-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-24
    P. End of Trial
    P.End of Trial StatusOngoing
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