Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study

Jill L. Schwartz, Christine Mauck, Jaim Jou Lai, Mitchell D Creinin, Vivian Brache, Susan A. Ballagh, Debra H. Weiner, Sharon L. Hillier, Raina N. Fichorova, Marianne Callahan

Research output: Contribution to journalArticle

76 Scopus citations

Abstract

Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. Methods: We performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active. Results: CS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR=2.02, 95% confidence interval=0.90-4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice. Conclusion: CS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials.

Original languageEnglish (US)
Pages (from-to)133-140
Number of pages8
JournalContraception
Volume74
Issue number2
DOIs
StatePublished - Aug 2006
Externally publishedYes

Keywords

  • Cellulose sulfate
  • Clinical trial
  • Contraception
  • Microbicide
  • Sexually transmitted infection

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynecology

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    Schwartz, J. L., Mauck, C., Lai, J. J., Creinin, M. D., Brache, V., Ballagh, S. A., Weiner, D. H., Hillier, S. L., Fichorova, R. N., & Callahan, M. (2006). Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study. Contraception, 74(2), 133-140. https://doi.org/10.1016/j.contraception.2006.02.008