CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 target
Drug / intervention
LACTIN-V +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00635622
NCT00635622Phase 2Completed
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A Phase IIa Study of the Colonization Efficiency, Safety and Acceptability of LACTIN-V Administered Vaginally to Women With Bacterial Vaginosis

Osel, Inc.·interventional·Posted Mar 14, 2008·Updated Jul 10, 2009

In Brief

A Phase 2 clinical trial evaluating LACTIN-V and Placebo control substance for Bacterial Vaginosis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
CountriesUnited States
CollaboratorsUniversity of California, San Francisco

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 14, 2008
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.3 years ago

Interventions

LACTIN-Vdrug

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.

Placebo control substancedrug

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.