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Effect of Estrogen & Stress for Postmenopausal Women

NCT00220454 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2007-02-27

No results posted yet for this study

Summary

The study tests the hypothesis that estradiol administration exacerbates the effects of the stress hormone cortisol on cognition and mood for postmenopausal women. This randomized, placebo-controlled, double-blind study was designed to examine the effects of an eight-week trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively healthy postmenopausal women were randomized to receive either placebo or estradiol skin patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at week 8.

Conditions

  • Aging

Interventions

DRUG

Climara

DRUG

Hydrocortone

Sponsors & Collaborators

  • National Alliance for Research on Schizophrenia and Depression

    collaborator OTHER

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Laura D Baker, PhD · VA Puget Sound Health Care System & University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Completion
2005-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220454 on ClinicalTrials.gov