title: Lea's Shield: colposcopic and microbiological testing during 8 weeks of use.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: CONRAD, Eastern Virginia Medical School, Department of Obstetrics and Gynecology, Arlington, VA 22209, USA. cmauck@conrad.org
authors.forename: Christine K
authors.initials: CK
authors.lastname: Mauck
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
authors.forename: Wes
authors.initials: W
authors.lastname: Rountree
authors.forename: Marianne M
authors.initials: MM
authors.lastname: Callahan
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
mesh_terms: D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000382:microbiology; D003075:Coitus; D015169:Colony Count, Microbial; D003127:Colposcopy; D003274:Contraceptive Devices, Female / Q000009:adverse effects / Q000382:microbiology*; D005260:Female; D006801:Humans; D008297:Male; D017137:Nonoxynol / Q000008:administration & dosage; D017060:Patient Satisfaction; D013089:Spermatocidal Agents / Q000008:administration & dosage; D013997:Time Factors; D014621:Vagina / Q000382:microbiology
chemical_list: D013089:Spermatocidal Agents; D017137:Nonoxynol