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
Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the
National Naval Medical Center.