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Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women

NCT ID: NCT00005768

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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This study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. Women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (\>70 yrs. of age) will take estrogen or placebo for three months. At the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). Previous research has shown that these dietary manipulations can briefly produce negative changes in mood. The investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. The investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. The proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.

Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Estrogen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal
* Non-smoker
* BMI \<30
* Healthy
* Without surgically-induced menopause
* Not on HRT or \>1 year post HRT
* Normal mammogram within last year
* No cardiovascular disease other than mild hypertension
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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University of Vermont

Burlington, Vermont, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julie Dumas

Role: CONTACT

Phone: 1-802-847-2523

Facility Contacts

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Julie Dumas

Role: primary

Other Identifiers

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M01RR000109

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00109-0741

Identifier Type: -

Identifier Source: org_study_id