Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm

The objectives were to assess the safety and acceptability of 2 vaginal microbicide gels (Acidform and BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm among low-risk sexually abstinent women. Eighty-one women enrolled in a randomized masked phase I safety study using a diaphragm with Acidform BufferGel or KY Jelly for 6 to 10 hours nightly for 14 nights. Physical examination colposcopy and lab studies were performed after 1 and 2 weeks of use. Diaries and questionnaires were used to assess user acceptability. Sixty-nine participants (85%) completed the study. Safety and acceptability appeared similar among the 3 study groups and no serious adverse events related to the study products were reported. Adverse events were mild and anticipated. Acidform and BufferGel compared to KY Jelly when used with diaphragm daily for 14 days appeared to be safe and acceptable in a small study of low-risk abstinent women. (authors)