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    Summary
    EudraCT Number:2020-001514-38
    Sponsor's Protocol Code Number:V1-27/03/2020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-20
    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 number2020-001514-38
    A.3Full title of the trial
    Effects of Ospemifene on brain activation patterns in women with sexual interest-arousal disorders.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of ospemifene on women's brain related to sexual disorders improvement.
    A.4.1Sponsor's protocol code numberV1-27/03/2020
    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 SponsorFundació Clínic Recerca Biomèdica
    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 supportFundació Clínic Recerca Biomèdica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Clínic Recerca Biomèdica
    B.5.2Functional name of contact pointSecretaria Ginecologia
    B.5.3 Address:
    B.5.3.1Street AddressVillaroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailsecgine@clinic.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Senshio
    D.2.1.1.2Name of the Marketing Authorisation holderShionogi B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vulvovaginal Atrophy
    E.1.1.1Medical condition in easily understood language
    Vulvovaginal dryness
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 changes from baseline in brain activation patterns, by using functional magnetic resonance imaging (fMRI) techniques and sexual stimuli, in postmenopausal women with moderate to severe vulvovaginal atrophy and FSIAD after 3 months treatment with ospemifene 60mg/day compared to those treated with placebo. fMRI technique allows the study of brain activation by detecting brain blood flow and oxygen level dependent changes induced by neuronal activation.
    The brain activation patterns will be defined by the number of voxels that significantly changed their signal intensity during the stimuli presentation compared to the neutral stimuli. Brain connectivity will be evaluated by using the activation map and the atlas of neuroanatomic regions and comparing the number of voxels, its level of significance and the different regions activated.
    E.2.2Secondary objectives of the trial
    To describe correlation between changes in vaginal maturation index and pH and brain activation pattern changes after 3 months of treatment.
    To describe if there is the correlation between changes in the visual examination of the vagina using the vaginal health index and brain activation pattern changes after 3 months of treatment.
    To describe the correlation between changes in the questionnaires performed and brain activation pattern changes after 3 months of treatment.
    To evaluate brain activation patterns after 3 months treatment with ospemifene (VVA ospemifene patients with FSIAD) versus brain activation patterns in these same patients at basal visit.
    To evaluate if the brain activation patterns after 3 months treatment with ospemifene are similar to the ones observed in women without FSIAD (VVA not treated patients without FSIAD) after 3 months.
    To evaluate the safety of the treatment with ospemifene 60mg/day and placebo in postmenopausal women with FSIAD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients have to follow all the inclusion criteria listed below to be included in the study:
    • Women 40 year old or older who have been diagnosed with menopause (either chemical, surgical or natural menopause)
    • No menstruation for at least a year.
    • Moderate or severe VVA diagnosis (defined by the presence of ≤ 5% of superficial cells and vaginal pH > 5).
    • For homogenisation of brain patterns, women had to be right-handed.
    • Women should be strictly heterosexual, in a stable relationship of at least 1 year duration (with expectations of remaining with the same relationship), and have had experience viewing sexually explicit images
    • For the FSIAD groups, women will be included if they are diagnosed with FSIAD, defined according to the criteria of DSM-V and confirmed by a structured clinical interview and by means of the scores of the SFQ and the FSDS-R (with a score of ≤20 for FSFI and ≥15 for the FSDS-R, respectively). These criteria will be an exclusion criterion for women without FSIAD.
    • Informed written consent of the patient.
    E.4Principal exclusion criteria
    • Women with known history of mental illness, history of drug or alcohol abuse.
    • Women with VVA treatment (oestrogens or ospemifene) at any time during the last 6 months, and/or laser treatment at any time during the last year.
    • Use of medication or herbal preparations at any time during the last 3 months for the purpose of improving sexual performance.
    • Women who have received any medication previous to the study inclusion, that may alter or interfere with brain activation patterns (psychoactive drugs).
    • Women with history of sexual offenses.
    • Women with abnormal vision that would impair the visualisation of the images and the olfactory stimuli.
    • Women with claustrophobia or implants that would preclude fMRI procedures.
    • Women with diagnosis of depression assessed by PHQ self-administered questionnaire.
    • Patients who had undergone vaginal surgery in the last 12 months.
    • Women who did not sign the written informed consent.
    • Hypersensitivity to the active substance or to any of the excipients included in Senshio.
    • Past or active history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
    • Unexplained vaginal bleeding.
    • Patients with suspected breast cancer or who are receiving active treatment (including adjuvant treatment) for breast cancer.
    • Suspicion of neoplasia or active neoplasia dependent on sex hormones (eg endometrial cancer).
    • Patients with signs or symptoms of endometrial hyperplasia; In this group of patients, safety has not been studied.
    E.5 End points
    E.5.1Primary end point(s)
    Brain activation patterns changes (with fMRI) after sexual stimuli (visual or olfactive), in postmenopausal women with moderate to severe VVA and FSIAD after 3 months treatment with ospemifene 60mg/day compared to those treated with placebo.
    During the fMRI session, the activation of each brain circuits/pattern is measured by the blood-oxygen level dependent (BOLD) signal and with the Statistical Parametric Mapping method regularly used in fMRI studies to visualize brain activation.
    For the longitudinal study, a paired t-test will be used within each group to detect changes in activation over time. The statistical threshold criterion to compare the different activation maps between both groups is p < 0.001 uncorrected with a minimum extent of 10 voxels. Only clusters that survive a p < 0.05 FWE (family wise error) correction for multiple comparisons will be considered statistically significant
    The region of interests who were mainly observed are: medial occipital gyrus, anterior cingulate cortex, bilateral thalamus, caudate nucleus, left pale globe, cerebellum, left inferior parietal lobe, postcentral gyrus, praecuneus, right medial frontal gyrus and left praecuneus.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    E.5.2Secondary end point(s)
    • To assess if there is a relation between brain activation pattern changes (blood flow changes in brain areas described measured by t-test) and changes in the vaginal maturation index (percentage of superficial and parabasal cells) as well as vaginal pH after 3 months of treatment.
    • To assess if there is a relation between brain activation pattern changes (blood flow changes in brain areas described measured by t-test) and changes in the visual examination of the vagina (clinical signs of vaginal dryness, petechiae, pallor, friability, and redness of the mucosa) measured according the vaginal health index after 3 months of treatment.
    • To assess if there is a relation between brain activation pattern changes (blood flow changes in brain areas described measured by t-test) and changes in the questionnaires:
    o FSFI questionnaire
    o DSM V questionnaire
    o SF-12 (QOL) questionnaire
    o FSDS-R (Female sexual distress scale-revised)
    o SFQ (Sexual function)
    o PHQ (self-reported questionnaire to discard depression) questionnaire after the 3 months of the inclusion in the study.
    • Describe changes in areas of the brain that will be activated after sexual stimuli (either visual or olfactory) in postmenopausal women with moderate to severe VVA and FSIAD treated with ospemifene for 3 months evaluated by fMRI which will be able to detect changes associated with blood flow versus areas of the brain activated after sexual stimuli (either visual or olfactory) in these same patients at basal visit. The evaluated areas will be the same as for the primary endpoint.
    • Areas of the brain that will be activated after sexual stimuli (either visual or olfactory) in postmenopausal women with moderate to severe VVA and FSIAD treated with ospemifene for 3 months evaluated by fMRI which will be able to detect changes associated with blood flow versus areas of the brain that will be activated after sexual stimuli (either visual or olfactory) in women without FSIAD (VVA not treated patients without FSIAD). The evaluated areas will be the same as for the primary endpoint.
    • Adverse events reported during the 3 months of follow-up of the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    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) No
    E.8.2.2Placebo Yes
    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 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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    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 state20
    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 Decision2020-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-06
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