Recruiting
Phase 2

Estrogen Modulation

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00005768

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Estrogen

Study Details

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.

Conditions

Menopause

Study ID

NCT00005768

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

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

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Estrogen

Central Contacts and Locations

Central contacts

Julie Dumas

1-802-847-2523

Locations

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Julie Dumas

802-847-2523

Principal Investigator:

Paul Newhouse, M.D.

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.