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    Summary
    EudraCT Number:2012-000752-33
    Sponsor's Protocol Code Number:SPL7013-016
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000752-33
    A.3Full title of the trial
    A phase 3, double-blind, multicenter, randomized, placebo-controlled study to assess the efficacy and safety of SPL7013 Gel (VivaGel®) for the treatment of bacterial vaginosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of SPL7013 Gel for the treatment of bacterial vaginosis
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberSPL7013-016
    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 SponsorStarpharma Pty Ltd
    B.1.3.4CountryAustralia
    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 supportStarpharma Pty Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStarpharma Pty Ltd
    B.5.2Functional name of contact pointClinical Development Manager
    B.5.3 Address:
    B.5.3.1Street AddressBaker IDI, 75 Commercial Road
    B.5.3.2Town/ cityMelbourne, Victoria
    B.5.3.3Post code3004
    B.5.3.4CountryAustralia
    B.5.4Telephone number0061385322700
    B.5.5Fax number0061395105955
    B.5.6E-mailinfo@starpharma.com
    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 nameVivaGel®
    D.3.2Product code SPL7013
    D.3.4Pharmaceutical form Vaginal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 676271-69-5
    D.3.9.2Current sponsor codeSPL7013
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 placeboGel
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bacterial vaginosis
    E.1.1.1Medical condition in easily understood language
    Depletion of naturally occurring protective bacteria in the vagina, and overgrowth of other bacteria
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 assess the efficacy of 1% SPL7013 Gel compared with placebo gel for the treatment of bacterial vaginosis (BV)
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability of 1% SPL7013 Gel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women who are 12 or older
    2. A diagnosis of BV defined as presentation with all of the four Amsel Criteria (i.e. all four of the following symptoms: presence of white to grey homogeneous discharge; positive whiff test [amine odor] following addition of potassium hydroxide [KOH] to a vaginal fluid sample; vaginal pH greater than 4.5; and presence of clue cells [≥20% of total epithelial cells]), and a Nugent score of ≥4 (patients may be enrolled pending Nugent score results provided a BV Blue® test is positive).
    3. Willing and able to provide written informed consent.
    4. Healthy as assessed by medical history and medical interview.
    5. If heterosexual or bisexual and of child-bearing potential, using an effective method of contraception with an intention to use this method for the duration of study participation, including one month after cessation of study product. An “effective method of contraception” is defined as: surgical sterilization; documented vasectomy of partner(s); intra-uterine device inserted at least 30 days prior to entry in to the study; lubricated condoms (that do not contain nonoxynol-9 [N-9]); or hormonal contraception (non-vaginally administered).
    6. Able to understand and willing to comply with study protocol procedures and restrictions.
    E.4Principal exclusion criteria
    1. Allergy or history of allergy to topical vaginal products, or to SPL7013 Gel, HEC placebo gel or their components.
    2. Abnormal pelvic examination at baseline that, in the investigator’s opinion, indicates the participant is unsuitable for the study, including presence of vulvovaginitis and/or cervicitis.
    3. Tests positive for Chlamydia, gonorrhea or trichomoniasis infection during screening (patients may be enrolled pending STI screening results); and/or signs/symptoms of active genital HSV-1 or HSV-2 infection.
    4. Participation in any other drug or device study less than 30 days prior to screening and/or prior participation in this or any other SPL7013 Gel study.
    5. Any social or medical condition precluding enrolment in to the study.
    6. Use of oral and/or vaginal antibiotics or antifungals within 14 days of enrolment.
    7. Tests positive for urinary tract infection (by urine dipstick) (women may be treated for their UTI and re-screened once the infection has fully resolved and exclusion criterion 7 is fulfilled).
    8. Reported clinically significant abnormalities on Papanicolaou (Pap) smear in previous 2 years (or in line with local guidelines) for participants over 21 years old (if not available, screening will be offered in accordance with local clinical guidance and patients may be enrolled with results pending). Clinically significant is defined as CIN2 or CIN3 changes.
    E.5 End points
    E.5.1Primary end point(s)
    E.5.1 Primary End Point (repeat as necessary) : Clinical Cure defined as resolution of clinical findings (i.e. Amsel criteria) from the Baseline visit (Day 1). Clinical Cure requires the status of specific Amsel criteria to be as follows: (i) the original discharge, characteristic of BV and meeting the Amsel criterion for abnormal discharge at baseline, has returned to normal physiological discharge, (ii) whiff test is negative for amine odor, and (iii) a saline wet-mount shows <20% clue cells.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of this endpoint: Test of Cure visit (TOC) (Day 21-30)
    E.5.2Secondary end point(s)
    Clinical cure
    Cure, defined as a Nugent score of 0-3
    Incidence of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical Cure: End of Treatment (EOT) visit (Day 9-12)

    Cure, defined as a Nugent score of 0-3: TOC visit and EOT visit

    Incidence of adverse events: At any time during study period (Baseline (Day 1) to TOC visit
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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 years0
    E.8.9.1In the Member State concerned months5
    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 months5
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Post-menarchal girls from 12-18 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 240
    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)
    Those women who have not responded to treatment, or who relapse, will be offered rescue therapy.
    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 Decision2012-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-05
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