Lea's Shield, a new barrier contraceptive preliminary clinical evaluations three-day tolerance study

Abstract

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.

PIP: Ten women wore the newly developed vaginal barrier contraceptive Lea's Shield for 72 hours so researchers could evaluate its acceptability. It is made of soft, pliable, nonabrasive, medical-grade silicone that does not support bacterial growth. It is an elliptical, cup-shaped device that completely covers the cervix, but is held in place by the suction created by the vaginal wall around it rather than by the cervix. A valve vents the air between the device and the cervix during insertion, which allows the device to settle in position and to drain cervical secretions and menstrual flow. The U-shaped control loop serves as a guide during insertion into the vagina, stabilizes the device's position, and allows the wearer to remove the device. Lea's Shield did not cause any vaginal trauma. None of the women experienced any changes in cervical cytology during the 3-day use of Lea's Shield. The contents of the bowl of Lea's Shield were less acidic than the vaginal environment, which might reduce the survival time and motility of sperm. No major changes occurred in the vaginal flora. The position of the uterus did not affect the ability of Lea's Shield to settle in place. These findings suggest that Lea's Shield is well tolerated by women. These findings, combined with positive results of previously conducted postcoital studies and of a large-scale efficacy study, indicate that this new type of contraception can be a significant new woman-controlled addition to the assortment of contraceptives.