Effects of Raloxifene on Hormone Levels
Effects of Raloxifene on Hormone Levels
Blood levels of the hormones estradiol and progesterone are of interest in evaluating ovarian
 function. However, because these hormone levels vary from day to day, blood samples must be
 taken very often or elaborately timed to specific phases of the menstrual cycle. A method has
 now been developed for measuring estradiol and progesterone levels in saliva. This study will
 test the accuracy of this method and examine whether salivary levels of these hormones change
 after treatment with raloxifene.

 Hormone levels will be measured during 3 menstrual cycles in women currently enrolled in the
 clinical study, "A Phase II Trial of Two Doses of Raloxifene in Women at Risk of Developing
 Invasive Breast Cancer." Participants will provide a saliva sample every morning for about a
 month during three collection periods-1 month before beginning raloxifene treatment, and 3
 and 12 months after treatment starts. Patients will be given kits for collecting the samples
 and mailing them to the laboratory at the end of each collection period.
Deviations from normal levels of serum E(2) and P are of interest in evaluating ovarian
 function. However, the day-to-day variations in these levels necessitates serial blood
 sampling or elaborate efforts to time blood draws within specific phases of the menstrual
 cycle. A noninvasive method for assessment of the levels of sex steroids on a daily basis
 using saliva has been developed. This study will assess the levels of estradiol and
 progesterone during 3 menstrual cycles (pre-drug and after 3 and 12 months of raloxifene
 therapy) in pre-menopausal women participating in a pilot chemoprevention trial of
 raloxifene.
Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the
 National Naval Medical Center.