NCT00635622

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

A Phase IIa Study of the Colonization Efficiency, Safety and Acceptability of LACTIN-V Administered Vaginally to Women With Bacterial Vaginosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Osel, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase IIa randomized, double blind, placebo-controlled, clinical trial of LACTIN-V at 2 x 10\^9 cfu/dose versus placebo, administered vaginally with a pre-filled applicator once daily for five consecutive days followed by a weekly dose over 2 additional weeks after an initial standardized antibiotic treatment with 0.75% topical metronidazole (MetroGel). A single site will enroll 40 participants (30 randomized to LACTIN-V and 10 to placebo). Colonization rate of Lactobacillus crispatus CTV 05 will be assessed with culture and rep-PCR. Safety will be determined by comparing the incidence of adverse events and serious adverse events in the LACTIN-V and placebo groups as determined by clinical symptoms, physical examination, pelvic examination with colposcopy and laboratory measurements. Tolerability will be measured by percentage of subjects who discontinue study product use due to overt adverse events and percentage of subjects who adhere to complete dosing schedule. Acceptability will be assessed via a standardized questionnaire and focus group discussions.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-03-14
• Last updated: 2009-07-10

Locations

1 site across 1 country: United States