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 Citations (Scopus)

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

Fingerprint

Colposcopy
Gels
Safety
Nonoxynol
Contraceptive Agents
Anti-Infective Agents
polystyrene sulfonic acid
Signs and Symptoms

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

Cite this

Single and multiple exposure tolerance study of polystyrene sulfonate gel : A Phase I safety and colposcopy study. / Mauck, Christine K.; Weiner, Debra H.; Ballagh, Susan A.; Creinin, Mitchell D; Archer, David F.; Schwartz, Jill L.; Pymar, Helen C.; Lai, Jaim Jou; Rencher, William F.; Callahan, Marianne M.

In: Contraception, Vol. 70, No. 1, 07.2004, p. 77-83.

Research output: Contribution to journalArticle

Mauck, CK, Weiner, DH, Ballagh, SA, Creinin, MD, Archer, DF, Schwartz, JL, Pymar, HC, Lai, JJ, Rencher, WF & Callahan, MM 2004, 'Single and multiple exposure tolerance study of polystyrene sulfonate gel: A Phase I safety and colposcopy study', Contraception, vol. 70, no. 1, pp. 77-83. https://doi.org/10.1016/j.contraception.2004.02.016
Mauck, Christine K. ; Weiner, Debra H. ; Ballagh, Susan A. ; Creinin, Mitchell D ; Archer, David F. ; Schwartz, Jill L. ; Pymar, Helen C. ; Lai, Jaim Jou ; Rencher, William F. ; Callahan, Marianne M. / Single and multiple exposure tolerance study of polystyrene sulfonate gel : A Phase I safety and colposcopy study. In: Contraception. 2004 ; Vol. 70, No. 1. pp. 77-83.
@article{7be9e9e59ec24692b5ea177c5576950e,
title = "Single and multiple exposure tolerance study of polystyrene sulfonate gel: A Phase I safety and colposcopy study",
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{\circledR} (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.",
keywords = "Contraception, Female, Microbicide, Phase I clinical trial, Polystyrene sulfonate, Sexually transmitted infections, Spermicide, Vaginal, Vaginal irritation",
author = "Mauck, {Christine K.} and Weiner, {Debra H.} and Ballagh, {Susan A.} and Creinin, {Mitchell D} and Archer, {David F.} and Schwartz, {Jill L.} and Pymar, {Helen C.} and Lai, {Jaim Jou} and Rencher, {William F.} and Callahan, {Marianne M.}",
year = "2004",
month = "7",
doi = "10.1016/j.contraception.2004.02.016",
language = "English (US)",
volume = "70",
pages = "77--83",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",
number = "1",

}

TY - JOUR

T1 - Single and multiple exposure tolerance study of polystyrene sulfonate gel

T2 - A Phase I safety and colposcopy study

AU - Mauck, Christine K.

AU - Weiner, Debra H.

AU - Ballagh, Susan A.

AU - Creinin, Mitchell D

AU - Archer, David F.

AU - Schwartz, Jill L.

AU - Pymar, Helen C.

AU - Lai, Jaim Jou

AU - Rencher, William F.

AU - Callahan, Marianne M.

PY - 2004/7

Y1 - 2004/7

N2 - 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.

AB - 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.

KW - Contraception

KW - Female

KW - Microbicide

KW - Phase I clinical trial

KW - Polystyrene sulfonate

KW - Sexually transmitted infections

KW - Spermicide

KW - Vaginal

KW - Vaginal irritation

UR - http://www.scopus.com/inward/record.url?scp=2942661726&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=2942661726&partnerID=8YFLogxK

U2 - 10.1016/j.contraception.2004.02.016

DO - 10.1016/j.contraception.2004.02.016

M3 - Article

C2 - 15208057

AN - SCOPUS:2942661726

VL - 70

SP - 77

EP - 83

JO - Contraception

JF - Contraception

SN - 0010-7824

IS - 1

ER -