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Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

Primary Purpose

Recurrent Bacterial Vaginosis (BV)

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
1% SPL7013 Gel
3% SPL7013 Gel
placebo gel
Sponsored by
Starpharma Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Bacterial Vaginosis (BV) focused on measuring BV, Bacterial vaginosis, recurrent, SPL7013 Gel, VivaGel

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
  • Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
  • Otherwise healthy

Exclusion Criteria:

  • No active STIs and/or current UTI
  • Previous exposure to SPL7013 Gel
  • A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1% SPL7013 Gel

    3% SPL7013 Gel

    placebo gel

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of women who have experienced a recurrent episode of BV as a measure of efficacy
    Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2011
    Last Updated
    October 27, 2013
    Sponsor
    Starpharma Pty Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01437722
    Brief Title
    Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
    Official Title
    A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Starpharma Pty Ltd

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Bacterial Vaginosis (BV)
    Keywords
    BV, Bacterial vaginosis, recurrent, SPL7013 Gel, VivaGel

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    205 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1% SPL7013 Gel
    Arm Type
    Experimental
    Arm Title
    3% SPL7013 Gel
    Arm Type
    Experimental
    Arm Title
    placebo gel
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    1% SPL7013 Gel
    Intervention Description
    vaginal gel
    Intervention Type
    Drug
    Intervention Name(s)
    3% SPL7013 Gel
    Intervention Description
    vaginal gel
    Intervention Type
    Drug
    Intervention Name(s)
    placebo gel
    Intervention Description
    vaginal gel
    Primary Outcome Measure Information:
    Title
    Number of women who have experienced a recurrent episode of BV as a measure of efficacy
    Description
    Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
    Time Frame
    Day 112 +/- 5

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode). Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria Otherwise healthy Exclusion Criteria: No active STIs and/or current UTI Previous exposure to SPL7013 Gel A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeremy Paull, PhD
    Organizational Affiliation
    Starpharma Pty Ltd
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

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