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    Summary
    EudraCT Number:2020-003254-76
    Sponsor's Protocol Code Number:20200518
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-003254-76
    A.3Full title of the trial
    Effects of local dehydroepiandrosterone (DHEA) and estradiol on moderate to severe dyspareunia, a symptom of vulvovaginal atrophy in postmenopausal women - a randomized, controlled study
    Effekter av vaginalt dehydroepiandrosteron (DHEA) och östradiol på måttlig till svår samlagssmärta, ett symtom på vulvovaginal atrofi hos postmenopausala kvinnor - en randomiserad, kontrollerad studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of local dehydroepiandrosterone (DHEA) and estradiol on moderate to severe dyspareunia due to vaginal dryness in postmenopausal women - a randomized, controlled study
    Effekter av vaginalt dehydroepiandrosteron (DHEA) och östradiol på måttlig till svår samlagssmärta, ett symtom på slidtorrhet hos postmenopausala kvinnor - en randomiserad, kontrollerad studie
    A.4.1Sponsor's protocol code number20200518
    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 SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    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 supportKarolinska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact point Clinical research unit
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska Vägen 37 A
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number46851773782
    B.5.6E-mailkvinnohalsan.kk.karolinska@sll.se
    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 Vagifem
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameEstradiol
    D.3.2Product code 41707
    D.3.4Pharmaceutical form Vaginal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal 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 Yes
    D.2.1.1.1Trade name Intrarosa
    D.2.1.1.2Name of the Marketing Authorisation holderEndoceutics S.A
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namePrasterone
    D.3.2Product code EMEA/H/C/004138 - N/0010
    D.3.4Pharmaceutical form Pessary
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vulvovaginal atrophy
    Måttlig till uttalad samlagssmärta beroende på slidtorrhet.
    E.1.1.1Medical condition in easily understood language
    Dyspareunia due to vaginal dryness
    Samlagssmärta vid slidtorrhet
    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
    Primary
    To compare the effect of intravaginal DHEA and estradiol on dyspareunia, a symptom of VVA in postmenopausal women
    Primary endpoint will be evaluated as change in dyspareunia (VASQ section 1) from baseline to Week 12
    Att jämföra effekten av Intrarosa och Vagifem på samlagssmärta vid slidtorrhet
    E.2.2Secondary objectives of the trial
    Secondary
    To evaluate the effect of local DHEA and estradiol on
    - total symptom score of VVA (vaginal dryness, irritation/itching, maturation index, pH)
    - clinical signs of VVA
    - sexual function
    - sex hormone levels
    - vaginal histomorphology
    - sex steroid hormone receptors
    - short-term safety
    Sekundära mål
    För att utvärdera effekten av Intrarosa och Vagifem på
    - symptom på vaginal torrhet, irritation / klåda, mognadsindex, pH
    - kliniska tecken på vaginal torrhet
    - sexuell funktion
    - könshormonnivåer
    - slidväggens tjocklek och sammansättning
    - könssteroidhormonreceptorer
    - kortvarig säkerhet
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Postmenopausal women (non-hysterectomized or hysterectomized) must satisfy either:
    a) No menses for at least one year for non-hysterectomized women OR
    b) Follicle stimulating hormone (FSH) levels >40 IU/L
    2. Women who have self-identified at screening and baseline as experiencing moderate to severe dyspareunia, using VASQ questionnaire
    3. Between 40 and 80 years of age
    4. Body mass index (BMI) 19-35
    5. Women having a vaginal pH above 5 at screening and baseline
    6. Women who currently have intercourse or other sexual activity, at least once a month, with a partner
    7. Normal mammogram within 12 months
    8. A normal PAP smear (which includes inflammatory changes) within the last 12 months (of baseline) for both non-hysterectomized.
    9. Willing to participate in the study and understand and sign a Swedish informed consent
    E.4Principal exclusion criteria
    1. Undiagnosed abnormal vaginal bleeding
    2. Previous diagnosis of cancer, except skin cancer (non-melanoma)
    3. Lichen Sclerosis and other pathological conditions in vulva and/or vagina
    4. Active or history of thromboembolic disease
    5. Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
    6. Oral estrogen, progestin or DHEA exposure or intrauterine progestin therapy in the 8 weeks prior to baseline assessments (screening visit)
    7. Vaginal hormonal products (rings, creams, gels or tablets) or transdermal estrogen alone or estrogen/progestin products in the 4 weeks prior to baseline assessments (screening visit)
    8. Use of testosterone or other anabolic steroid within 6 months prior to screening visit
    9. Natural oral estrogenic products in the 4 weeks prior to baseline assessments
    10. Confirmed clinically significant depression (not controlled by standard therapy) or confirmed history of severe psychiatric disturbance
    11. The administration of any investigational drug within 30 days of screening visit
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable in the study is the difference at week 12, between the two treatment arms, in the proportion of patients obtaining a VASQ (section 1) score improvement (from baseline) of ≥1 reflecting an improvement of dyspareunia
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 12 of treatment
    E.5.2Secondary end point(s)
    Secondary efficacy variables (total symptom score of VVA):
    - Change from baseline to week 4 and week 12 in vaginal dryness (none, mild, moderate or severe) as patient evaluation through completion of VASQ (section 2)
    - Change from baseline to week 4 and week 12 in vulvovaginal irritation/itching (none, mild, moderate or severe) as patient evaluation through completion of VASQ (section 3)
    - Mean change from baseline to week 4 and week 12 in vaginal pH

    Secondary efficacy variables (clinical signs of VVA):
    - Change from baseline to week 4 and week 12 in pallor, friability, thinning/flattening of folds, petechiae and dry mucosa (none, mild, moderate or severe ratings) as evaluated by gynecologist

    Secondary efficacy variables (sexual function):
    - Mean change from baseline to week 4 and week 12 in the different domains (desire, arousal, orgasm, pleasure, concern, responsiveness and self-image) of PFSF (Profile of Female Sexual Function) will be evaluated by patient self-completion

    Secondary exploratory variables (sex steroid hormones/metabolites/proteins):
    - Mean change from baseline to week 4 and week 12 for estrogens, androgens, metabolites and SHBG

    Secondary exploratory variables (vaginal histomorphology and sex steroid hormone receptor levels):
    - Vaginal histomorphology (thickness and nerve density in the epithelium, muscularis and lamina propria) and receptors (estrogen α/β, androgen and progesterone) will be evaluated in 30 women in each treatment arm at baseline, Week 4 and Week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 4 and 12 of treatment
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state170
    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)
    Post trial treatment can be offered if requested
    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 Decision2020-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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