Expired Study
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Bethesda, Maryland 20892


Purpose:

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 summary:

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.


Criteria:

Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the National Naval Medical Center.


Study is Available At:


Original ID:

990180


NCT ID:

NCT00026962


Secondary ID:

99-C-0180


Study Acronym:


Brief Title:

Effects of Raloxifene on Hormone Levels


Official Title:

Assessment of the Effects of Raloxifene on Salivary Estradiol and Progesterone Levels


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:


Study Dates

Start Date:September 1999
Completion Date:August 2003
Verification Date:August 2003
Last Changed Date:March 3, 2008
First Received Date:November 14, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:measuring estradiol and progesterone levels in sal

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:8215051
Reference Type:Reference
Citation: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.
PMID:2180689
Reference Type:Reference
Citation: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.
PMID:1958572

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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