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Salivary Assays for Estradiol and Progesterone

PI: PI: Linda LeResche, Ph.D., Research Professor, Oral Medicine, School of Dentistry, University of Washington

The relevance of variation in hormone levels to a number of aspects of women's health is now widely recognized. The importance of developing non-invasive methods for detecting hormonal variation (e.g., through collection of saliva) is becoming clear. At two recent NIH conferences attended by the PI (one sponsored by the Office of Research on Women's Health, to develop the research agenda for women's health for the 21st Century and one on Gender and Pain) NIH personnel requested that researchers consider the use of such measures and provide feedback on whether these measures are now sufficiently well developed or if their development should be a priority for funding agencies. Within our own institution, another RCDRC-funded investigator is taking a similar approach to measuring hormones related to puberty (testosterone in boys, progesterone and estradiol in girls) using salivary samples.

The specific aims of this study are to adapt standard radioimmunoassay kits for estradiol and progesterone so that they provide reproducible measures of estradiol and progesterone in saliva, and to use the modified assays to analyze the levels of estradiol and progesterone in saliva samples collected daily from healthy female subjects over the course of one menstrual cycle Data will be graphed to demonstrate that salivary estradiol and progesterone assayed by these techniques follow the same temporal pattern over the menstrual cycle as estradiol and progesterone in serum.

Initial results are based on samples collected from five subjects. Data for progesterone from the whole unstimulated saliva samples followed the expected pattern of the menstrual cycle, with a peak in the mid-luteal phase for all subjects. Progesterone data for the sac samples was similar, with the exception that one subject showed a slightly higher progesterone level in her Day 14 sample than her Day 20 sample. The correlation of levels of progesterone in the whole, unstimulated samples with levels in the sac samples was moderate (r2 = 0.41). Data for estradiol in both sac and whole saliva samples were more problematic, possibly due to the much lower levels of estradiol in saliva. No correlation was found between estradiol levels detected in the sac and those from the whole, unstimulated samples (r2 = -0.08).

This project has stimulated the interest of the manufacturers of the saliva sac as well as an independent private sector salivary analysis firm. A small business grant has been submitted by these firms for further development of a saliva sac tailored to saliva collection for hormone analysis, as well as reliable, valid salivary assays for ovarian hormones. Dr. Gandara will serve as a consultant to this SBIR grant.

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