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

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ClinicalTrials.gov Identifier: NCT00005768
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : June 2, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Menopause Drug: Estrogen Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005768


Contacts
Contact: Julie Dumas 1-802-847-2523

Locations
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Julie Dumas    802-847-2523      
Principal Investigator: Paul Newhouse, M.D.         
Sponsors and Collaborators
National Center for Research Resources (NCRR)
More Information

ClinicalTrials.gov Identifier: NCT00005768     History of Changes
Other Study ID Numbers: NCRR-M01RR00109-0741
M01RR000109 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Additional relevant MeSH terms:
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs