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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Postmenopause

Treatments: Drug: Comparator: placebo; Drug: Comparator: Estrace

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799708

094

0000-094

2008_592

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo

2

Active Comparator group

Description:

Estrace 0.5 mg

Treatment:

Drug: Comparator: Estrace

3

Active Comparator group

Description:

Estrace 2 mg

Treatment:

Drug: Comparator: Estrace