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 are 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. There are five patients enrolled currently. No compli- cations have been encountered so far, and we plan to continue this study.
