Effect of Estrogen & Stress for Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00220454
First received: September 19, 2005
Last updated: February 26, 2007
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Aging
Drug: Climara
Drug: Hydrocortone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Estrogen on the Stress Response for Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Change in cognitive test scores at months 1 & 3 vs. baseline

Secondary Outcome Measures:
  • Correlation between change in blood levels of cortisol & estradiol and cognitive scores
  • Correlation between change in cognitive score and treatment-induced change in beta-amyloid

Estimated Enrollment: 40
Study Start Date: December 2002
Estimated Study Completion Date: March 2005
Detailed Description:

Estrogen replacement has been associated with improved learning and memory in both animal and human studies. However, there is some evidence to suggest that “stress” has a detrimental effect on learning for female animals who still have naturally circulating estrogen. Interestingly, when the effects of this hormone are blocked in the body, stress no longer impairs learning. Several investigators have raised the possibility that the physiological response to stress may be exaggerated for women compared to men. Gender differences in biological systems that control the release of gonadal and stress hormones may explain why estrogen is beneficial for women under nonstressed conditions, but detrimental for them under stressed conditions. To date, no study has carefully controlled or manipulated both estrogen use and cortisol levels to further explore this issue. In this placebo-controlled, double blind, parallel-group design clinical study we will evaluate whether estrogen use exacerbates stress-related impairments in cognition for healthy postmenopausal women. Forty subjects will receive either 0.10 mg/day of transdermal beta-estradiol or a placebo skin patch for 8 weeks. In the last week of treatment, subjects will receive 90 mg/day of oral hydrocortisone or a placebo for 4 consecutive days. Scores on tests of memory, attention, and mood, as well as blood levels of estrogen and cortisol will be assessed at baseline, and at weeks 4 and 8. We predict that the estrogen+cortisol combination will have a deleterious effect on cognition and mood relative to the effects of either hormone administered alone. The results of this study are likely to provide important information regarding not only the nature of the interaction between these hormonal systems that occurs in response to stress, but also the conditions under which the beneficial effects of estrogen may be overshadowed.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Postmenopausal women

Exclusion Criteria:

Current HRT use Hx of DVT current steroid user Cushing's or other similar disease Breast or uterine cancer

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220454

Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Laura D Baker, PhD VA Puget Sound Health Care System & University of Washington
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220454     History of Changes
Other Study ID Numbers: RDIS 0007, Baker-Y02 (Sponsor), BL17 (Supporting Institution)
Study First Received: September 19, 2005
Last Updated: February 26, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
cognition
estradiol
cortisol
postmenopause

Additional relevant MeSH terms:
Estrogens
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014