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    The EU Clinical Trials Register currently displays   40977   clinical trials with a EudraCT protocol, of which   6698   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000375-25
    Sponsor's Protocol Code Number:BotA-KKDS2016
    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:2016-02-29
    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 number2016-000375-25
    A.3Full title of the trial
    Double blind placebo-controlled RCT of the efficacy and safety of intramuscular injections of Botulinum Toxin A as a treatment for provoked vestibulodynia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for Botox as treatment for provoked vestibulodynia
    A.3.2Name or abbreviated title of the trial where available
    BotA-KKDS2016
    A.4.1Sponsor's protocol code numberBotA-KKDS2016
    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 SponsorDanderyds sjukhus AB
    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 supportNational Vulvodynia Association
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDanderyds sjukhus AB
    B.5.2Functional name of contact pointDept of Obstetrics and Gynecology
    B.5.3 Address:
    B.5.3.1Street AddressDanderyds sjukhus
    B.5.3.2Town/ cityDanderyd
    B.5.3.3Post code182 88
    B.5.3.4CountrySweden
    B.5.4Telephone number46812355000
    B.5.6E-mailnina.bohm-starke@s.se
    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 Botox (botulinum toxin 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.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) Yes
    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 placeboSolution for injection/infusion
    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
    Provoked vestibulodynia
    E.1.1.1Medical condition in easily understood language
    Long-lasting pain around the vaginal opening causing severe pain during vaginal intercourse and tampon insertion.
    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
    The reduction of patient self-reported dyspareunia and/or pain at tampon insertion as measured by Visual Analogue Scale 0 (no pain) to 100 (worst pain imaginable)
    E.2.2Secondary objectives of the trial
    The reduction of pelvic floor hyperactivity/tonus, measured with a vaginal manometer, safety aspects and effect duration of BTA, influence on quality of life and psychosexual evaluation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-40 years
    • PVD defined as significant pain at vestibular contact and vaginal entry (VAS ≥ 6 at the tampon test or severe pain, preventing intercourse)
    • Duration of symptoms of ≥ 3 months
    • Nullipara.
    • Patients who are willing to participate in the study after it has been explained orally and in writing will be included.

    E.4Principal exclusion criteria
    • Local infection, dermatological conditions or other causes to dyspareunia,
    • Major psychiatric or medical disease (peripheral motor neurological disease such as myasthenia gravis, amyotrophic lateral sclerosis or Lambert-Eaton syndrome and diabetes)
    • Pregnancy
    • Pelvic floor deficiency with urine and or flatulence incontinence.
    E.5 End points
    E.5.1Primary end point(s)
    Pain score in millimetres from "no pain" will be analysed as a continuous variable and compared between groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The patients will be asked to indicate with an X on a 100 mm long line marked with "no pain" to the left hand side and "worst imaginable pain" at the right hand side (Visual Analogue Scale- VAS) how much pain has during vaginal intercourse and/or tampon insertion. The first evaluation is before randomisation and treatment (baseline) and related to experienced pain the last month. The patients will then regularly report weekly in a diary the pain during vaginal intercourse and/or tampon insertion and also report at the follow ups, see below.
    E.5.2Secondary end point(s)
    Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups.
    The hyperactivity of the pelvic floor muscles will be analysed by vaginal pressure measurements using a plastic catheter (4 mm) with a pressure transducer at the top. Resting tonus, maximum contraction strength and 10 s endurance of contraction will be measured in cm H2O.

    Questionnaires on general health and reproductive health will be filled out at baseline. Questionnaires on sexual dysfunction and distress and quality of life will be filled out.
    • Female Sexual Function Index (FSFI)
    • Female Sexual Distress Scale (FSDS)
    • Quality of life (WHOQOL-BRIEF, Swedish version and EQ-5D)
    • PSS (perceived stress scale),
    • Anxiety questionnaire (Spence, Swedish version).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups.
    The vaginal pressure will be measured before treatment and at all follow-ups;
    Visit 2, 4-6 weeks after baseline
    Visit 3, 12 weeks after baseline
    Visit 4, 16-18 weeks after baseline
    Visit 5, 6 months after baseline
    Visit 6, final study visit, 12 months from baseline.
    The questionnaires will be filled out at baseline. visit 3 , 5 and 6.
    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) Yes
    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 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 years4
    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: 90
    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 state90
    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)
    After the trial is finished, the participants who have received placebo will be offered to receive the active treatment with Botox (botulinum toxin A) in the same way and doses as during the trial if the result of the trial shows that Botox is safe (no serious adverse events) and is more effective than placebo. For post trial treatment, the patients have to pay for the medication, the treatment is otherwise free of charge. This information is included in "Patient Information" of the trial.
    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 Decision2016-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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