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Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis

NCT01437722•Starpharma Pty Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

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.

Key Dates

Start Date

August 1, 2011

Primary Completion Date

December 1, 2012

Last Updated

November 20, 2013

Enrollment

205

ACTUAL participants

Conditions

Recurrent Bacterial Vaginosis (BV)

Interventions

1% SPL7013 Gel

DRUG

3% SPL7013 Gel

DRUG

placebo gel

DRUG