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Lea's Shield: colposcopic and microbiological testing during 8 weeks of use
Christine K Mauck1, Mitchell D Creinin, Wes Rountree
1CONRAD, Eastern Virginia Medical School, Department of Obstetrics and Gynecology, Arlington, VA 22209, USA. cmauck@conrad.org
Contraception
|June 21, 2005
Summary
Lea's Shield with nonoxynol-9 spermicide caused mild genital irritation in some users and altered vaginal microflora, but no clinical infections were observed during 8 weeks of use.
Area of Science:
- Reproductive Health
- Microbiology
Background:
- Female genital irritation and changes in vaginal microflora are potential concerns with contraceptive device use.
- Nonoxynol-9 spermicide is commonly used but can cause local side effects.
Purpose of the Study:
- To evaluate the effects of Lea's Shield plus nonoxynol-9 spermicide on female genital irritation.
- To assess changes in cervical and vaginal microflora during 8 weeks of use with intercourse.
- To identify user-related problems associated with Lea's Shield.
Main Methods:
- Open-label, single-arm study design.
- Participants underwent pelvic examinations and colposcopy.
- Vaginal and cervical cultures were performed.
Main Results:
- 13% of women reported irritation symptoms; one-third had minor colposcopic findings.
- Increased bacterial counts (Enterococcus, E. coli, anaerobic gram-negative rods) were noted.
- No clinical infections were diagnosed, though most users reported usage problems.
Conclusions:
- Lea's Shield use is linked to minor genital irritation in a subset of users.
- Vaginal microflora changes occurred but did not correlate with clinical infections.
- The device is associated with user-reported issues, despite a lack of infection.