Single and multiple exposure tolerance study of polystyrene sulfonate gel: A Phase I safety and colposcopy study

Christine K. Mauck, Debra H. Weiner, Susan A. Ballagh, Mitchell D Creinin, David F. Archer, Jill L. Schwartz, Helen C. Pymar, Jaim Jou Lai, William F. Rencher, Marianne M. Callahan

Research output: Contribution to journalArticle

18 Scopus citations

Abstract

Objectives To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide. Methods Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol® (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days. Results All women completed the study except one in the Conceptrol group who experienced vaginal symptoms after her first use and was discontinued. After both the first use and after all uses, irritation was seen among more women in the Conceptrol group than in the PSS groups, reaching statistical significance with regard to any evidence of irritation, signs of irritation and product-related irritation. There were no adverse events that were serious, unexpected and related to product use in any group. The 5% concentration of PSS may be preferable in terms of leakage and acceptability. Conclusion The results suggest that PSS has a safety profile comparable to that of the marketed nonoxynol-9 product, Conceptrol, and appears to be associated with less genital irritation.

Original languageEnglish (US)
Pages (from-to)77-83
Number of pages7
JournalContraception
Volume70
Issue number1
DOIs
StatePublished - Jul 2004
Externally publishedYes

Keywords

  • Contraception
  • Female
  • Microbicide
  • Phase I clinical trial
  • Polystyrene sulfonate
  • Sexually transmitted infections
  • Spermicide
  • Vaginal
  • Vaginal irritation

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynecology

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    Mauck, C. K., Weiner, D. H., Ballagh, S. A., Creinin, M. D., Archer, D. F., Schwartz, J. L., Pymar, H. C., Lai, J. J., Rencher, W. F., & Callahan, M. M. (2004). Single and multiple exposure tolerance study of polystyrene sulfonate gel: A Phase I safety and colposcopy study. Contraception, 70(1), 77-83. https://doi.org/10.1016/j.contraception.2004.02.016