Expired Study

Clinical Trial 3057

San Francisco, CA 94110

Study Summary:

This is an industry-sponsored Phase II study to test a vaginal powder made of naturally occurring Lactobacilli that can prevent the occurrence of bacterial vaginosis.

You will be asked to use an applicator filled with a test powder in your vagina once a day for 5 days then once a week for the following two weeks.

You will get a free exam and lab tests at the first study visit. If you are diagnosed with bacterial vaginosis at this time, you will be given a 5 day course of 0.75% topical Metronidazole (MetroGel) therapy, the standard antibiotic treatment for bacterial vaginosis. One week later, you will return for your lab results. The results of these tests will determine if you are eligible to join the study.

If you are eligible, you will receive the pre-filled applicators and asked to use it once a day at bedtime for the next 5 days, then once a week for the following two weeks. Over the next 28 days, you will have 2 more exam visits and will be invited to participate in a focus group to discuss your experiences with the product. Throughout the study you will keep a record of how you use the pre-filled applicators and how you are feeling.
