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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopause

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: placebo

Drug

placebo capsule once daily for 7 days.

Comparator: Estrace

Drug

Estrace 0.5 mg or 2 mg tablets once daily for 7 days.

Other names: Estrace

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

Secondary outcomes

Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.

Time frame: Baseline and Day 7

Change from baseline in unstimulated labial gland saliva flow rate at Day 7

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Dec 1, 2008
Registry last updated: Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed