Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

Official Title
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A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: 0.5% SPL7013 Gel
* Drug: 1.0% SPL7013 Gel
* Drug: 3.0% SPL7013 Gel
* Other: Placebo Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4 Otherwise healthy Exclusion Criteria: No active STIs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: 0.5% SPL7013 Gel<br> | Drug: 0.5% SPL7013 Gel<br>* Vaginal gel<br>|
| Experimental: 1.0% SPL7013 Gel<br> | Drug: 1.0% SPL7013 Gel<br>* Vaginal gel<br>|
| Experimental: 3.0% SPL7013 Gel<br> | Drug: 3.0% SPL7013 Gel<br>* Vaginal gel<br>|
| Placebo Comparator: Placebo Gel<br> | Other: Placebo Gel<br>* Vaginal gel<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 as a Measure of Efficacy | Number of women with clinical cure as determined by absence of BV by the Amsel's criteria | Day 21-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women With Clinical Cure as a Measure of Efficacy | Number of women with clinical cure as determined by absence of BV by the Amsel's criteria | Day 9-12 | 
| Number of Women With Nugent Cure as a Measure of Efficacy | Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline. | Day 9-30 | 
| Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor. | Day 9-30 | 
| Incidence of Genital Adverse Events Potentially Related to Treatment | Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety. | For the duration of the study (up to Visit Day 21-30) | 

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