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Contraception. 2010 Dec;82(6):563-71. doi: 10.1016/j.contraception.2010.04.019. Epub 2010 May 26.

Expanded safety and acceptability of the candidate vaginal microbicide CarraguardĀ® in South Africa.

Erratum in

  • Contraception. 2011 Nov;84(5):539. Williams, Manuela M [corrected to Williams, Maria Manuela].

Abstract

BACKGROUND:

Carraguard's safety and acceptability was assessed among women in Gugulethu and Ga-Rankuwa, South Africa.

STUDY DESIGN:

A randomized, placebo-controlled, triple-blind trial was conducted in HIV-negative, nonpregnant women who inserted Carraguard or placebo at least three times a week, including before vaginal sex, for 6 to 12 months. Monthly visits included pelvic examination, sexually transmitted infection (STI) testing/treatment and HIV counseling/testing. Acceptability was assessed quarterly.

RESULTS:

Of 400 women (205 Carraguard, 195 placebo) enrolled, 328 (77%) completed at least 6 months. Incidence of genital epithelial disruption was similar between the Carraguard (13.6 per 100 woman-years) and placebo (21.3 per 100 woman-years) groups (relative risk, 0.64; 95% confidence interval, 0.37-1.10); there were no significant differences in rates of HIV/STI, though the study was not powered to determine effectiveness. Only 2% of adverse events were judged possibly related to (either) gel. More than 94% of women reported at least once liking the gel very much.

CONCLUSIONS:

Carraguard was not associated with more vaginal, cervical or external genital irritation than placebo, and it was acceptable when used approximately 3.5 times per week, including during sex.

Copyright Ā© 2010 Elsevier Inc. All rights reserved.

PMID:
21074021
[PubMed - indexed for MEDLINE]
PMCID:
PMC2983477
Free PMC Article

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