This protocol was developed as a companion protocol to #98-CC-0123. It allows us to study the reproductive effects of raloxifene in premenopausal women by transvaginal color Doppler sonography and sonohysterography with correlation to steroid hormones. Raloxifene is a selective estrogen modulating agent that is being evaluated as a potential chemopreventive agent in patients at high risk for breast cancer. The safety and efficacy of raloxifene are being evaluated under protocol #98-CC-0123. Little data is available regarding the gynecological effects of raloxifene in premenopausal women. The purpose of our study is to study both the short-term and the long-term effects of raloxifene on ovulation frequency, endometrial development, and cyclic function in general. The study started enrolling patients in January 1999. To date 15 patients have been enrolled. One subject was dropped due to irregular menstrual cycles which made her ineligible. Three additional subjects dropped off from the protocol due to inability to comply with multiple study evaluations for logistic reasons.As the parent protocol (98-C-0123) has completed accrual, no more patients will be enrolled into this protocol either. The protocol accrual therefore has been completed but the patients currently enrolled are still being followed and we have not yet answered the research objectives.
