Status:
COMPLETED
A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Postmenopause
Eligibility:
FEMALE
40+ years
Phase:
PHASE1
Brief Summary
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00799708
Start Date
May 1 2008
End Date
October 1 2008
Last Update
March 16 2016
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