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

July 8, 2019 updated by: Starpharma Pty Ltd

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

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

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Key eligibility criteria:

  • Post-menarchal females, aged 12 years or more
  • Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
  • Nugent score of at least 4
  • Otherwise healthy, as determined by medical history, physical examination
  • normal Pap smear at or documented within 24 months of screening

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: VivaGel
Drug: 1% SPL7013 Gel
Vaginal gel, daily for 7 days
Other Names:
  • VivaGel
PLACEBO_COMPARATOR: HEC Placebo
Drug: Placebo
Vaginal gel, daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
Time Frame: Day 9-12
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Day 9-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Women With Nugent Cure at the EOT Visit
Time Frame: Day 9-12
Nugent Cure is defined as a Nugent score of 0-3 (normal)
Day 9-12
Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
Time Frame: Day 21-30
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Day 21-30
Number of Women With Nugent Cure at the TOC Visit
Time Frame: Day 21-30
Nugent Cure is defined as a Nugent score of 0-3 (normal)
Day 21-30
Adverse Events Potentially Related to Treatment
Time Frame: Screening/baseline through TOC visit, Day 1-30
Number of participants with adverse events considered potentially related to study treatment
Screening/baseline through TOC visit, Day 1-30

Collaborators and Investigators

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

Sponsor

Starpharma Pty Ltd

Investigators

  • Study Chair: 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 (ACTUAL)

March 28, 2012

Primary Completion (ACTUAL)

July 20, 2012

Study Completion (ACTUAL)

July 20, 2012

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (ESTIMATE)

April 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPL7013-015

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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