A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Status:
Completed
Trial end date:
2012-10-05
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to
placebo gel for the treatment of bacterial vaginosis (BV).
After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or
hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime
for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and
Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12)
and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day
21-30).