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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

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