Phase 1 N=27 Randomized Double-blind Diagnostic

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

Postmenopause

Bottom Line

View on ClinicalTrials.gov: NCT00799708 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2010

Primary outcome: 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 — 0.028; -0.011; 0.080 Fold change — p=0.345

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Comparator: placebo (Drug); Comparator: Estrace (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
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	0.028; -0.011; 0.080	0.345
SECONDARY Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.	-0.26; -0.64	0.120

Summary

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

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00799708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.