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

Postmenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799708
• Other study ID #: 0000-094
• Secondary ID: 0942008_592
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2008
• Last updated: February 18, 2016
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• Comparator: placebo
placebo capsule once daily for 7 days.
• Comparator: Estrace
Estrace 0.5 mg or 2 mg tablets once daily for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No