NCT01577238

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Starpharma Pty Ltd · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	1% SPL7013 Gel	Vaginal gel, daily for 7 days
DRUG	Placebo	Vaginal gel, daily for 7 days

Timeline

• Start date: 2012-03-28
• Primary completion: 2012-07-20
• Completion: 2012-07-20
• First posted: 2012-04-13
• Last updated: 2019-07-17
• Results posted: 2019-07-09