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

Phase 1

Completed

• Conditions: Postmenopause

• Registration Number: NCT00799708
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Results First Submitted: 2010-06-25
• Results First Submitted QC: 2010-06-25
• Results First Posted: 2010-07-29
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Baseline and 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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.	Baseline and Day 7	Change from baseline in unstimulated labial gland saliva flow rate at Day 7