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. There are 25 patients enrolled currently. No complications have been encountered so far and we plan to continue this study.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL000080-03
Application #
6543060
Study Section
(DRD)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code