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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Recurrent Bacterial Vaginosis (BV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1% SPL7013 Gel

Group Type EXPERIMENTAL

1% SPL7013 Gel

Intervention Type DRUG

vaginal gel

3% SPL7013 Gel

Group Type EXPERIMENTAL

3% SPL7013 Gel

Intervention Type DRUG

vaginal gel

placebo gel

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

vaginal gel

Interventions

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1% SPL7013 Gel

vaginal gel

Intervention Type DRUG

3% SPL7013 Gel

vaginal gel

Intervention Type DRUG

placebo gel

vaginal gel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No