Lea's Shield, a new barrier contraceptive preliminary clinical evaluations three-day tolerance study.
In this study the Lea's Shield was evaluated for its tolerance by women who wore the device for three consecutive days. Ten women who wore the Lea's Shield for 72 hours completed the tolerance study without adverse effects. Examination of the cervix and vagina revealed that the device did not provoke any significant cellular or microbial changes among the wearers. No major changes in the appearance or prevalence of vaginal flora occurred in the women after three days of wearing the device. A gradient in the pH could be detected between the contents of the vagina, which was more acidic than the contents of the bowl of the device. The range of cervical shapes and vaginal morphology among the study participants has had no influence upon the ability of the device to remain in its proper position. The device "settles in place" as it is pushed in, thereby obviating any special maneuvers for proper positioning. No vaginal nor cervical trauma occurred. We have concluded from these basic clinical evaluations that Lea's Shield is well tolerated during three days of use. Efficacy trials in women at risk recently completed have confirmed the high degree of acceptability and that the device can function adequately as one size fits all.
Hunt
W L
WL
YAMA, Inc., Millburn, NJ.
Gabbay
L
L
Potts
M
M
D002584:Cervix Uteri / Q000382:microbiology / Q000473:pathology; D003274:Contraceptive Devices, Female / Q000009:adverse effects / Q000592:standards*; D005260:Female; D006194:Gardnerella vaginalis / Q000302:isolation & purification; D006801:Humans; D006863:Hydrogen-Ion Concentration; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D013211:Staphylococcus aureus / Q000302:isolation & purification; D013997:Time Factors; D014621:Vagina / Q000382:microbiology / Q000473:pathology