Back to resultsA 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
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring SPL7013, VivaGel, bacterial vaginosis, BV
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
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 with adverse events considered potentially related to study treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01577238
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
March 28, 2012 (Actual)
Primary Completion Date
July 20, 2012 (Actual)
Study Completion Date
July 20, 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
250 (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 with 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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