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

NCT00799708 | Completed Phase 1 Results

• 3 other identifiers: 0000-0940942008_592
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postmenopause

Keywords

Biomarkers of estrogen receptor beta activation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Baseline and Day 7

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo

2

ACTIVE COMPARATOR

Estrace 0.5 mg

Drug: Comparator: Estrace

3

ACTIVE COMPARATOR

Estrace 2 mg

Drug: Comparator: Estrace

Interventions

Comparator: placebo DRUG

placebo capsule once daily for 7 days.

1

Comparator: Estrace DRUG

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

Also known as: Estrace

2; 3

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 16, 2016
• Results First Posted: July 29, 2010

Record last verified: 2016-02