The role of biopsy in vaginal microbicide development.

The technique of vaginal biopsy has been used to provide an objective assessment of inflammation in phase I vaginal microbicide studies conducted at Imperial College, London, since 1995. Biopsies are taken from the cervical aspect of the right fornix before product exposure at baseline, and from the cervical aspect of the left fornix at follow-up. We have found biopsy to be a simple, safe, and effective means of assessing genital inflammation in selected populations. Using this technique, inflammatory infiltrates can be characterized and agents with different modes of action can be compared. Vaginal biopsy is most useful in early phase I studies in sexually abstinent populations.