A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00799708

Purpose

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

Condition	Intervention	Phase
Postmenopause	Drug: Comparator: placebo Drug: Comparator: Estrace	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

Further study details as provided by Merck:

Primary Outcome Measures:

Difference in ERbeta-specific gene signature after treatment with 2 mg, 0.5 mg, or no estradiol. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in minor gland salivary flow rate after treatment with 2 mg estradiol vs placebo. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	April 2008
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Comparator: placebo placebo capsule once daily for 7 days.
2: Active Comparator Estrace 0.5 mg	Drug: Comparator: Estrace Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
3: Active Comparator Estrace 2 mg	Drug: Comparator: Estrace Estrace 0.5 mg or 2 mg tablets once daily for 7 days.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799708

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_592, 094
Study First Received:	November 26, 2008
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00799708 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Merck:

Biomarkers of estrogen receptor beta activation

Study placed in the following topic categories:

Estrogens
Hormone Antagonists
Estradiol 3-benzoate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists

Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Hormones
Estradiol

Additional relevant MeSH terms:

Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones
Pharmacologic Actions
Estradiol

ClinicalTrials.gov processed this record on September 10, 2009