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  • Title: Lea's Shield: colposcopic and microbiological testing during 8 weeks of use.
    Author: Mauck CK, Creinin MD, Rountree W, Callahan MM, Hillier SL.
    Journal: Contraception; 2005 Jul; 72(1):53-9. PubMed ID: 15964293.
    Abstract:
    OBJECTIVES: The aims of this study were to assess the effects of Lea's Shield(R) plus nonoxynol-9 spermicide on signs and symptoms of female genital irritation and cervical and vaginal microflora during 8 weeks of use with intercourse and to analyze problems associated with the use of the device. METHODS: In this open-label, single-arm study, participants were evaluated by pelvic examination, colposcopy and vaginal and cervical cultures. RESULTS: About 13% of women (4/30) reported symptoms of irritation, and minor product-related colposcopic findings were seen in about one third (11/30). Although average colony counts for enterococcus, Escherichia coli and anaerobic gram-negative rods increased during product use, no clinical diagnoses of infection were made. Most users reported at least one problem using Lea's Shield. CONCLUSION: Lea's Shield, when used for 8 weeks during intercourse, is associated with evidence of genital irritation in a minority of users and with changes in vaginal microflora that do not appear to correlate with clinical infections.
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