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Robert T Chatterton Jr, JoAnne Zujewski, Esnar T Mateo, Jennifer Eng-Wong and V Craig Jordan

Raloxifene is a selective oestrogen receptor modulator used clinically for the treatment and the prevention of osteoporosis in postmenopausal women. The drug has been evaluated in the Study of Tamoxifen and Raloxifene as an agent to reduce breast cancer incidence in postmenopausal women at high risk. However, about 30% of women who develop breast cancer do so in their premenopausal years. In this pilot study, salivary oestradiol and progesterone were determined throughout the menstrual cycle for a total of 22 subjects, 14 of whom completed pre- and postraloxifene (60 mg daily) salivary collections. The mean concentration of oestradiol during the menstrual cycle when subjects were taking raloxifene was significantly greater (P<0.001) than during baseline cycles. Neither salivary progesterone and cortisol nor menstrual cycle length were affected by raloxifene treatment. These data demonstrate that raloxifene administered to premenopausal women increases the concentration of oestradiol that diffuses into the salivary glands, and which presumably represents the concentration available to other organs as well. The results reflect increases in serum oestradiol reported earlier.

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Robert T Chatterton Jr, Esnar T Mateo, Nanjiang Hou, Alfred W Rademaker, Simbi Acharya, V Craig Jordan and Monica Morrow

The objective of the study was to characterize salivary sex steroid levels in 56 women undergoing annual mammography who were participating in a breast density study at the Lynn Sage Breast Center of Northwestern Memorial Hospital, and to determine the predictability of the patterns within women. Saliva was collected daily by the women at home for one complete menstrual cycle and then again at approximately 6-month intervals. The occurrence of sporadic anovulatory cycles was identified in 12 subjects, and persistent oestradiol (OE2) elevation in all three cycles without significant progesterone levels occurred in another five subjects. In addition, both OE2 and progesterone were significantly lower in initial menstrual cycles than in subsequent cycles, suggestive of an effect of participation in the study on hormone levels. Initial salivary OE2 levels were not good predictors of corresponding levels in either follicular or luteal phases of the menstrual cycles at the 6-month intervals. However, after the initial cycle, progesterone levels were highly predictable within individuals over a period of 6 months (r=0.78, P< 0.001). The study emphasizes the natural variation among and within women in the absence of any intervention, and indicates the need for properly controlled studies before attributing changes in hormonal levels to therapy. In addition, it emphasizes the importance of sampling at multiple time points when examining the relationship between hormones and risk.