Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

June 3, 2019 updated by: Starpharma Pty Ltd

A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis

The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • Colorado
      • Denver, Colorado, United States, 80218
        • Downtown Women's Health Care
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center of Nevada
    • Texas
      • Irving, Texas, United States, 75061
        • Bexar Clinical Trials, LLC
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research Inc

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 diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
  • Otherwise healthy

Exclusion Criteria:

  • No active STIs

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.5% SPL7013 Gel
Drug: 0.5% SPL7013 Gel
Vaginal gel
EXPERIMENTAL: 1.0% SPL7013 Gel
Drug: 1.0% SPL7013 Gel
Vaginal gel
EXPERIMENTAL: 3.0% SPL7013 Gel
Drug: 3.0% SPL7013 Gel
Vaginal gel
PLACEBO_COMPARATOR: Placebo Gel
Other: Placebo Gel
Vaginal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Women With Clinical Cure as a Measure of Efficacy
Time Frame: Day 21-30
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Day 21-30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Women With Clinical Cure as a Measure of Efficacy
Time Frame: Day 9-12
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Day 9-12
Number of Women With Nugent Cure as a Measure of Efficacy
Time Frame: Day 9-30
Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.
Day 9-30
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Time Frame: Day 9-30
Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.
Day 9-30
Incidence of Genital Adverse Events Potentially Related to Treatment
Time Frame: For the duration of the study (up to Visit Day 21-30)
Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.
For the duration of the study (up to Visit Day 21-30)

Collaborators and Investigators

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

Sponsor

Starpharma Pty Ltd

Investigators

  • Principal Investigator: Anne Macek, MD, contracted to 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, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

September 12, 2010

First Posted (ESTIMATE)

September 14, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPL7013-013

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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