Sexually Transmitted Diseases

Skip Navigation LinksHome > December 2007 - Volume 34 - Issue 12 > Phase I Safety Trial of Two Vaginal Microbicide Gels (Acidfo...
Sexually Transmitted Diseases:
doi: 10.1097/OLQ.0b013e31813347e9
Article

Phase I Safety Trial of Two Vaginal Microbicide Gels (Acidform or BufferGel) Used With a Diaphragm Compared to KY Jelly Used With a Diaphragm

WILLIAMS, D’NYCE L. MD*; NEWMAN, DANIEL R.†; BALLAGH, SUSAN A. MD‡; CREININ, MITCHELL D. MD§; BARNHART, KURT MD|; WEINER, DEBRA H. MPH¶; BELL, APRIL J. MPH†; JAMIESON, DENISE J. MD†

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Abstract

Objectives: 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.

Study Design: 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.

Results: 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.

Conclusions: 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.

© Copyright 2007 American Sexually Transmitted Diseases Association

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