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...
Date First Received: November 14, 2001
Last Updated: March 3, 2008
Verified by: National Institutes of Health Clinical Center (CC), August 2003
Clinical Trial Phase: Phase 2 | Start Date: September 1999
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
Official Title: “Assessment of the Effects of Raloxifene on Salivary Estradiol and Progesterone Levels”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Detailed Clinical Trial Description
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.
Intervention(s) in this Clinical Trial
- Procedure: measuring estradiol and progesterone levels in saliva
Criteria for Participation in this Clinical Trial
- Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the National Naval Medical Center.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Cancer Institute (NCI)
Related Publications
References
Read GF. Status report on measurement of salivary estrogens and androgens. Ann N Y Acad Sci. 1993 Sep 20;694:146-60. Review. No abstract available.
Rosner W. The functions of corticosteroid-binding globulin and sex hormone-binding globulin: recent advances. Endocr Rev. 1990 Feb;11(1):80-91. Review. No abstract available.
Petra PH. The plasma sex steroid binding protein (SBP or SHBG). A critical review of recent developments on the structure, molecular biology and function. J Steroid Biochem Mol Biol. 1991;40(4-6):735-53. Review.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00026962
Study ID Number: 990180
ClinicalTrials.gov Identifier: NCT00026962
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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