Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

October 27, 2013 updated by: Starpharma Pty Ltd

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

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
  • Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
  • Otherwise healthy

Exclusion Criteria:

  • No active STIs and/or current UTI
  • Previous exposure to SPL7013 Gel
  • A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1% SPL7013 Gel
Drug: 1% SPL7013 Gel
vaginal gel
EXPERIMENTAL: 3% SPL7013 Gel
Drug: 3% SPL7013 Gel
vaginal gel
PLACEBO_COMPARATOR: placebo gel
Drug: placebo gel
vaginal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of women who have experienced a recurrent episode of BV as a measure of efficacy
Time Frame: Day 112 +/- 5
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
Day 112 +/- 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Starpharma Pty Ltd

Investigators

  • Study Director: Jeremy Paull, PhD, Starpharma Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (ESTIMATE)

September 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2013

Last Update Submitted That Met QC Criteria

October 27, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPL7013-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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