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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: 1% SPL7013 Gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VivaGel<br> | Drug: 1% SPL7013 Gel<br>* Vaginal gel, daily for 7 days<br>* Other names: VivaGel;|
| Placebo Comparator: HEC Placebo<br> | Drug: Placebo<br>* Vaginal gel, daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Day 9-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women With Nugent Cure at the EOT Visit | Nugent Cure is defined as a Nugent score of 0-3 (normal) | Day 9-12 | 
| 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) | Day 21-30 | 
| Number of Women With Nugent Cure at the TOC Visit | Nugent Cure is defined as a Nugent score of 0-3 (normal) | Day 21-30 | 
| Adverse Events Potentially Related to Treatment | Number of participants experiencing adverse events considered potentially related to study treatment. | Screening/baseline through TOC visit, Day 1-30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPL7013, VivaGel, bacterial vaginosis, BV