NCT00026962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Sep 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2003

First QC Date

November 14, 2001

Last Update Submit

March 3, 2008

Conditions

Breast Cancer

Keywords

BreastHormonesPreventionSalivaSerum

Interventions

measuring estradiol and progesterone levels in salivaPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the National Naval Medical Center.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Read GF. Status report on measurement of salivary estrogens and androgens. Ann N Y Acad Sci. 1993 Sep 20;694:146-60. doi: 10.1111/j.1749-6632.1993.tb18349.x. No abstract available.

    PMID: 8215051BACKGROUND

  • Rosner W. The functions of corticosteroid-binding globulin and sex hormone-binding globulin: recent advances. Endocr Rev. 1990 Feb;11(1):80-91. doi: 10.1210/edrv-11-1-80. No abstract available.

    PMID: 2180689BACKGROUND

  • 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. doi: 10.1016/0960-0760(91)90299-k.

    PMID: 1958572BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2001

First Posted

November 15, 2001

Study Start

September 1, 1999

Study Completion

August 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-08

Locations

US(1)