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Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis

NCT00635622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-07-10

No results posted yet for this study

Summary

This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

LACTIN-V

Vaginal application of single-use applicators pre-filled with LACTIN-V (Formulation 1) at 2 x 10\^9 cfu/dose or placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.

DRUG

Placebo control substance

Vaginal application of single-use applicators pre-filled with placebo control substance. The study product will be administered once daily for 5 consecutive days, followed by once weekly application over 2 consecutive additional weeks.

Sponsors & Collaborators

Principal Investigators

  • Craig R Cohen, MD, MPH · University of California, San Francisco

  • Anke Hemmerling, MD, MPH, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00635622 on ClinicalTrials.gov