CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 251 enrolled
Drug / intervention
1% SPL7013 Gel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01577537
NCT01577537Phase 3Completed
CompareCT.gov

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

Starpharma Pty Ltd·interventional·Posted Apr 16, 2012·Updated Jul 17, 2019

In Brief

A Phase 3 clinical trial evaluating 1% SPL7013 Gel and Placebo for Bacterial Vaginosis. Completed, enrolled 251 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2012
Enrollment StartApr 17, 2012
Primary CompletionOct 5, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.2 years ago

Interventions

1% SPL7013 Geldrug

Vaginal gel, daily for 7 days

Placebodrug

Vaginal gel, daily for 7 days