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
Sponsor study identifier
interventional
205
0 countries
N/A
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
Not reported
Date not reportedThe purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2011
Actual (reported)September 21, 2011
Actual (reported)December 2012
Actual (reported)Number of women who have experienced a recurrent episode of BV as a measure of efficacy
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
Day 112 +/- 5
vaginal gel
vaginal gel
Jeremy Paull, PhD
Starpharma Pty Ltd
205 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2011
First Posted
September 21, 2011
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
vaginal gel
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Last Updated
November 20, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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