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

D'Nyce L. Williams, Daniel R. Newman, Susan A. Ballagh, Mitchell D Creinin, Kurt Barnhart, Debra H. Weiner, April J. Bell, Denise J. Jamieson

Research output: Contribution to journalArticle

30 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)977-984
Number of pages8
JournalSexually Transmitted Diseases
Volume34
Issue number12
DOIs
StatePublished - Dec 2007
Externally publishedYes

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Microbiology (medical)

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