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NCT00005768 Clinical Trial

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

Menopause Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00005768
Other study ID # NCRR-M01RR00109-0741
Secondary ID M01RR000109
Status Recruiting
Phase Phase 2
First received June 1, 2000
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact Julie Dumas
Phone 1-802-847-2523
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Estrogen

Locations
Country Name City State
United States University of Vermont Burlington Vermont

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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