 Washout pre-trial: Prior treatment of ovarian hormone replacement therapy should be stopped at least 28 days prior to registration. Use of other investigational drugs should be stopped within 28 days of enrollment. No major surgery within 28 days before enrollment Major surgery is defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability. 