POPLINE Document Number: 194563
Author(s):
Mauck CK
Weiner DH
Ballagh SA
Creinin MD
Archer DF
Source citation:
Contraception, 2004 Jul;70(1):77-83.
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. (author's)
Keywords:
United StatesIndex page
Research Report
Clinical Trials
Women
Signs and Symptoms
Genital Effects, Female
Drugs
Infection Prevention
Vaginal Approach
Microbicides
Contraception
Vaginal Spermicides
Developed Countries
North America
Americas
Clinical Research
Research Methodology
Demographic Factors
Population
Diseases
Genitalia, Female
Genitalia
Urogenital System
Physiology
Biology
Treatment
Infections
Female Sterilization
Sterilization, Sexual
Family Planning
Contraceptive Methods