NCT00220454

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

September 19, 2005

Last Update Submit

February 26, 2007

Conditions

Aging

Keywords

cognitionestradiolcortisolpostmenopause

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive test scores at months 1 & 3 vs. baseline

Secondary Outcomes (2)

  • 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

Interventions

ClimaraDRUG
HydrocortoneDRUG

Eligibility Criteria

Age55 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EstradiolHydrocortisone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanes11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex Hormones17-Hydroxycorticosteroids

Study Officials

  • Laura D Baker, PhD

    VA Puget Sound Health Care System & University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

December 1, 2002

Study Completion

March 1, 2005

Last Updated

February 27, 2007

Record last verified: 2007-02