This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
27
placebo capsule once daily for 7 days.
Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7
Subset of genes on the log ratio intensity scale from a microarray platform - signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens- quantified as a ratio of up regulated versus down regulated genes
Time frame: Baseline and Day 7
Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.
Change from baseline in unstimulated labial gland saliva flow rate at Day 7
Time frame: Baseline and Day 7
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