Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.