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Clinical Trials/NCT00005768
NCT00005768UnknownPhase 2

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

National Center for Research Resources (NCRR)2 sites in 1 countryStarted: June 2, 2000Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Locations
2

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Postmenopausal
  • Non-smoker
  • Without surgically-induced menopause
  • Not on HRT or >1 year post HRT
  • Normal mammogram within last year
  • No cardiovascular disease other than mild hypertension

Exclusion Criteria

  • Not provided

Investigators

Sponsor
National Center for Research Resources (NCRR)
Sponsor Class
Nih

Study Sites (2)

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