Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Bacterial Vaginosis Clinical Trial

Official title: A Phase I Study of the Safety of LACTIN-V Administered Vaginally to Healthy Women

Status Completed

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to demonstrate that LACTIN-V is safe, well tolerated, and acceptable to healthy pre-menopausal women when administered vaginally using pre-filled applicators at doses of 150 mg (5.0 x 10^8 CFU), 300 mg (1.0 x 10^9 CFU), or 600 mg (2.0 x 10^9 CFU) daily for 5 consecutive days as compared to placebo applicators containing 150 mg, 300 mg, or 600 mg of a matching placebo formulation without Lactobacillus crispatus CTV-05.

Safety will be assessed by:

• Incidence and severity of adverse events through assessing symptoms, physical examination findings, and signs of irritation involving the external genitalia, cervix or vagina, including disruption of the epithelium and blood vessels as seen on pelvic examination and colposcopy.

• Laboratory parameters including urinalysis, a complete blood count (CBC) with differential, and chemistry panels to assess systemic effects of the study product.

Tolerability will be assessed by:

• The proportion of participants who discontinue study product use due to overt adverse events

• The proportion of participants who complete the full dosing schedule

Acceptability will be assessed by:

• Self-administered questionnaires and focus group discussions about acceptability of the study product ;

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginosis, Bacterial

• NCT number: NCT00537576
• Study type: Interventional
• Source: Osel, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Completion date: April 2008