There is a compelling public health interest in perfecting female condoms that line the vagina and protect the female genital tract against exposure to semen and potentially infected genital secretions. This research compares a new design of female condom with the only comparable product marketed in the U.S. today. The commercially available product is anchored by an external ring that only partially covers the perineum and can be accidentally pushed into the vagina during intercourse. The new design attaches a disposable latex condom to the midsection of specially designed cotton underwear. The condom is naturally inserted into the vagina during intercourse by the penetration of the penis. The underwear anchors the condom liner during intercourse completely shielding the external genitalia. This prospective crossover study will enroll thirty-five couples not at-risk of pregnancy to use three condoms of each type in a randomized sequence. Couples will complete a report after each condom use in addition to a questionnaire that assess condom acceptability. The study will evaluate breakage, slippage of the condom within and outside of the vagina, and performance problems such as penile rerouting beside the condom. Secondary objectives will include assessment of product acceptability and product safety.
At this time, there are no products currently available that protect women with the same efficacy as male condoms protect men The JANESWAY(tm) female condom is an innovative woman-controlled barrier contraceptive under development that shows great potential to protect against sexually transmitted disease. It is designed to give complete barrier protection for the female mucosa, both inside the vagina and the exposed area outside, thus preventing any fluid exchange during sex. Initial testing will determine what if any final product modifications should be made before beginning a larger breakage/slippage and efficacy trial. JANESWAY(tm) is on track for premarket approval under FDA guidance for commercialization of a new female condom.
