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

Merck Sharp & Dohme LLC0 sites27 target enrollmentMay 2008

ConditionsPostmenopause

DrugsComparator: placebo Comparator: Estrace

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Postmenopause
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 27
Primary Endpoint: 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
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

October 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Time Frame: 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