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

February 18, 2016 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: Comparator: placebo
placebo capsule once daily for 7 days.
Active Comparator: 2
Estrace 0.5 mg
Drug: Comparator: Estrace
Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
Other Names:
  • Estrace
Active Comparator: 3
Estrace 2 mg
Drug: Comparator: Estrace
Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
Other Names:
  • Estrace

What is the study measuring?

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
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
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.
Time Frame: Baseline and Day 7
Change from baseline in unstimulated labial gland saliva flow rate at Day 7
Baseline and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-094
  • 094
  • 2008_592

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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