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


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

990180

NCT ID:

NCT00026962

Start Date:

September 1999

Completion Date:

August 2003

Related Keywords:

  • Breast Cancer
  • Breast
  • Hormones
  • Prevention
  • Saliva
  • Serum
  • Breast Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892