Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026962
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-14
Brief Title:
Effects of Raloxifene on Hormone Levels
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Assessment of the Effects of Raloxifene on Salivary Estradiol and Progesterone Levels
Status:
COMPLETED
Status Verified Date:
2003-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Deviations from normal levels of serum E2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0180 | None | None | None |