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

NCT01201057 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-06-06

Study results available
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Summary

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

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

0.5% SPL7013 Gel

Vaginal gel

DRUG

1.0% SPL7013 Gel

Vaginal gel

DRUG

3.0% SPL7013 Gel

Vaginal gel

OTHER

Placebo Gel

Vaginal gel

Sponsors & Collaborators

  • Starpharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Anne Macek, MD · contracted to Starpharma Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201057 on ClinicalTrials.gov