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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01577238
Study type Interventional
Source Starpharma Pty Ltd
Contact
Status Completed
Phase Phase 3
Start date March 28, 2012
Completion date July 20, 2012

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