Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: Effects on markers of inflammation and innate immunity in cervicovaginal fluid

Deborah J. Anderson, D'Nyce L. Williams, Susan A. Ballagh, Kurt Barnhart, Mitchell D Creinin, Daniel R. Newman, Frederick P. Bowman, Joseph A. Politch, Ann C. Duerr, Denise J. Jamieson

Research output: Contribution to journalArticle

17 Scopus citations


Objective: Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. Method of study: Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex® (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14days in combination with one of the two acid-buffering microbicide gels [ACIDFORM™ (Instead Inc., La Jolla, CA, USA) or BufferGel™ (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly®; Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA. Results: Use of diaphragms with placebo or microbicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group. Conclusions: Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations.

Original languageEnglish (US)
Pages (from-to)121-129
Number of pages9
JournalAmerican Journal of Reproductive Immunology
Issue number2
StatePublished - 2009
Externally publishedYes



  • Cytokines
  • Diaphragm
  • Human immunodeficiency virus
  • Inflammation
  • Innate immunity
  • Microbicides

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy
  • Obstetrics and Gynecology
  • Reproductive Medicine

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