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Title: Saliva Sample May Predict First Onset of Menses: Presented at PAS

"Saliva Sample May Predict First Onset of Menses: Presented at PAS"

By Louise Gagnon TORONTO, CANADA -- May 9, 2007 -- Saliva can be sampled as a marker for hormonal concentrations to assist in determining the first onset of menses in young girls, according a late breaking poster session here at the annual meeting of the Pediatric Academic Societies (PAS). Investigators sought to find a means to test for either the positive predictive value of the onset of menses or the negative predictive value of the onset of menses. "It's unknown how to predict the first onset of menses," said Susan Gray, MD, assistant professor, department of paediatrics, Boston University School of Medicine and attending paediatrician, division of young adult and adolescent medicine, Boston Medical Center, Boston, Massachusetts, United States. "We usually look at indicators such as breast development, pubic hair, and body mass index [BMI] in terms of predicting the very first period. Using saliva is a non-invasive means of assessing when menarche will occur. They are more comfortable with spitting in a tube than in having blood drawn," Dr. Gray explained. Being able to predict the onset of menses would be useful in various treatment settings, including oncology, noted Dr. Gray. "If young girls are undergoing chemotherapy, they may be put at risk if they have a period while undergoing chemotherapy," she said. "You might want to give them therapy to suppress their first period when their platelet counts are low." Investigators first recruited 63 healthy females, aged nine to 15, who had not begun menstruation. The girls were classified as having a Tanner stage of III or more in their pubertal development, and their body mass index was above the 5[^th percentile.

Saliva samples were collected on a weekly basis for 12 months or until first menses. Investigators recorded monthly height and weight. They also took assays to assess hormonal concentrations, including salivary 17-beta estradiol, testosterone, progesterone, and 17-hydroxyprogesterone (17-OHP). Based on the results of the measurements, statistical models were used to construct formulas for menses onset within 30, 45, 60, and 90 days, with the predictors being given saliva samples, hormonal levels, and BMI.

Three girls withdrew with no menarche in first 60 days. Of the 60 who remained, 12 completed a year of assessments without beginning menstruation. The majority (43) completed evaluations with menarche, 12 of whom began their first menstrual bleeding in 60 days or less, and 31 who began after 60 days. Five subjects withdrew from the study after 60 days with no menstruation.

The models found salivary hormone levels to be a more accurate predictor than BMI. A formula which included oestradiol, 17-OHP, testosterone, and BMI showed sensitivity of 80%, specificity of 83%, a positive predictive value of 54%, and a negative predictive value of 94%, in predicting menarche within 60 days.

"If the girl had a negative test, we were 94% sure that she would not get her period in the next two months," said Dr. Gray. "We would want to validate the models in a larger sample in girls of different pubertal stages and improve upon the positive predictive value."

Johnson and Johnson Consumer and Personal Products Worldwide funded the study.

[Presentation title: Predicting Imminent Menarche from Salivary Steroid Hormones and Body Mass Index: A Pilot Study. Poster 7937.17]

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