Effects of Raloxifene on Hormone Levels

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID
NCT00026962
Run by
National Cancer Institute (NCI)
People needed
60
Starts
1999-09-01
Expected to finish
2003-08-01
Last updated by the study team
2008-03-04

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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