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

Starpharma Pty Ltd205 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

205

Conditions

Recurrent Bacterial Vaginosis (BV)

Interventions

1% SPL7013 GelDRUG

vaginal gel

3% SPL7013 GelDRUG

vaginal gel

placebo gelDRUG

vaginal gel

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of women who have experienced a recurrent episode of BV as a measure of efficacy

Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria

Time frame: Day 112 +/- 5

Data from ClinicalTrials.gov

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