Effects of Raloxifene on Hormone Levels
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: measuring estradiol and progesterone levels in saliva (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: National Cancer Institute (NCI)
Summary
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.
Clinical Details
Official title: Assessment of the Effects of Raloxifene on Salivary Estradiol and Progesterone Levels
Study design: Treatment, Safety/Efficacy Study
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the
National Naval Medical Center.
Locations and Contacts
National Cancer Institute (NCI), Bethesda, Maryland 20892, United States
Additional Information
Related publications: 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.
Starting date: September 1999
Ending date: August 2003
Last updated: March 3, 2008
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