AgingPhase 2NCT00220454
Effect of Estrogen & Stress for Postmenopausal Women
A Phase 2 study testing Climara and Hydrocortone in people with Aging, run by Seattle Institute for Biomedical and Clinical Research.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Climara and Hydrocortone
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
Who cannot join
- Current HRT use Hx of DVT current steroid user Cushing's or other similar disease Breast or uterine cancer
About this study
Official title: Effect of Estrogen on the Stress Response for Postmenopausal Women
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Climara, Hydrocortone
- Keywords
- cognition, estradiol, cortisol, postmenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClimaraDrug
HydrocortoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Investigators
- Laura D Baker, PhD, Principal investigator, VA Puget Sound Health Care System & University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220454
- Sponsor's protocol ID
- RDIS 0007
- Other IDs
- Baker-Y02 (Sponsor), BL17 (Supporting Institution)
- Status last verified
- Feb 2007
- First submitted
- 19 Sep 2005
- Last updated
- 27 Feb 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Estrogen on the Stress Response for Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00220454
- Acronym / sponsor ID
- RDIS 0007
- Conditions
- Aging
- Keywords
- cognition, estradiol, cortisol, postmenopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Dec 2002
- Study completion
- Mar 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women
Key exclusion criteria (1 listed)
- Current HRT use Hx of DVT current steroid user Cushing's or other similar disease Breast or uterine cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Climara | Drug | – |
| Hydrocortone | Drug | – |
Primary outcome
Change in cognitive test scores at months 1 & 3 vs. baseline
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura D Baker, PhD principal investigator
VA Puget Sound Health Care System & University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Climara and Hydrocortone in people with Aging, run by Seattle Institute for Biomedical and Clinical Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive test scores at months 1 & 3 vs. baseline. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.