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Safety Study of Lactobacillus Administered Vaginally to Healthy Women

NCT00537576 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-09-16

Study results available
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Summary

The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.

Conditions

  • Bacterial Vaginosis

Interventions

BIOLOGICAL

Low dose LACTIN-V applicator

Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU), administered vaginally once a day for 5 consecutive days

BIOLOGICAL

Medium dose LACTIN-V applicator

Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days

BIOLOGICAL

High dose LACTIN-V applicator

High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU), administered vaginally once a day for 5 consecutive days

OTHER

Low dose Placebo applicator

Low dose Placebo applicator (150 mg Placebo), administered vaginally once a day for 5 consecutive days

OTHER

Medium dose Placebo

Medium dose Placebo applicator (300 mg Placebo), administered vaginally once a day for 5 consecutive days

OTHER

High dose Placebo applicator

High dose Placebo applicator (600 mg Placebo), administered vaginally once a day for 5 consecutive days

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-03-31
Completion
2008-04-30

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 NCT00537576 on ClinicalTrials.gov