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A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Primary Purpose

Bacterial Vaginosis

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

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring SPL7013, VivaGel, bacterial vaginosis, BV

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key eligibility criteria:

  • Post-menarchal females, aged 12 years or more
  • Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
  • Nugent score of at least 4
  • Otherwise healthy, as determined by medical history, physical examination
  • normal Pap smear at or documented within 24 months of screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    VivaGel

    HEC Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

    Secondary Outcome Measures

    Number of Women With Nugent Cure at the EOT Visit
    Nugent Cure is defined as a Nugent score of 0-3 (normal)
    Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
    Number of Women With Nugent Cure at the TOC Visit
    Nugent Cure is defined as a Nugent score of 0-3 (normal)
    Adverse Events Potentially Related to Treatment
    Number of participants experiencing adverse events considered potentially related to study treatment.

    Full Information

    First Posted
    April 12, 2012
    Last Updated
    July 8, 2019
    Sponsor
    Starpharma Pty Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01577537
    Brief Title
    A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
    Official Title
    A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 17, 2012 (Actual)
    Primary Completion Date
    October 5, 2012 (Actual)
    Study Completion Date
    October 5, 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Vaginosis
    Keywords
    SPL7013, VivaGel, bacterial vaginosis, BV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    251 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VivaGel
    Arm Type
    Experimental
    Arm Title
    HEC Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    1% SPL7013 Gel
    Other Intervention Name(s)
    VivaGel
    Intervention Description
    Vaginal gel, daily for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Vaginal gel, daily for 7 days
    Primary Outcome Measure Information:
    Title
    Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
    Description
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
    Time Frame
    Day 9-12
    Secondary Outcome Measure Information:
    Title
    Number of Women With Nugent Cure at the EOT Visit
    Description
    Nugent Cure is defined as a Nugent score of 0-3 (normal)
    Time Frame
    Day 9-12
    Title
    Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
    Description
    Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
    Time Frame
    Day 21-30
    Title
    Number of Women With Nugent Cure at the TOC Visit
    Description
    Nugent Cure is defined as a Nugent score of 0-3 (normal)
    Time Frame
    Day 21-30
    Title
    Adverse Events Potentially Related to Treatment
    Description
    Number of participants experiencing adverse events considered potentially related to study treatment.
    Time Frame
    Screening/baseline through TOC visit, Day 1-30

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key eligibility criteria: Post-menarchal females, aged 12 years or more Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells Nugent score of at least 4 Otherwise healthy, as determined by medical history, physical examination normal Pap smear at or documented within 24 months of screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeremy Paull, PhD
    Organizational Affiliation
    Starpharma Pty Ltd
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

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