A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)

Study Overview
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Brief Summary
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This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: Comparator: placebo
* Drug: Comparator: Estrace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is healthy, postmenopausal woman at least 40 years of age with onset of menopause within 10 years of screening Subject has a normal mammogram at screening Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not had a Pap-smear in the last 3 years will have the option to have the test at screening Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva flow Subject is willing to avoid strenuous exercise during the study Subject is willing to avoid use of mouthwash or salt water rinses during the study Subject is willing to avoid use of teeth whitening products Subject is willing to avoid eating and/or drinking grapefruit products Subject is willing to limit alcohol consumption to 2 drinks a day Subject is willing to limit caffeine consumption to 3 cups of coffee (or equivalent) per day Subject is a non-smoker Exclusion Criteria: Subject has a history of multiple and/or severe allergies to drugs or food Subject has a cold or viral infection within 2 weeks of Visit 2 Subject is taking antibiotics within 2 weeks of Visit 2 Subject needs dental work or procedures during the study Subject has used any estrogen or progesterone preparation or product containing phytoestrogens within 3 months of screening Subject is unable to discontinue anti-coagulants

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Comparator: placebo<br>* placebo capsule once daily for 7 days.<br>|
| Active Comparator: 2<br>Estrace 0.5 mg | Drug: Comparator: Estrace<br>* Estrace 0.5 mg or 2 mg tablets once daily for 7 days.<br>* Other names: Estrace;|
| Active Comparator: 3<br>Estrace 2 mg | Drug: Comparator: Estrace<br>* Estrace 0.5 mg or 2 mg tablets once daily for 7 days.<br>* Other names: Estrace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers of estrogen receptor beta activation