Trials / Completed
CompletedNCT02122198
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- Female
- Age
- 40 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Complaints about memory and thinking are common in women as they go through menopause and estrogen levels fall. The ovarian hormone estrogen is important for supporting normal cognitive function, and changes in brain activity and function occur when estrogen levels are decreased. Estrogen is also important for maintaining healthy blood vessels which also support normal cognitive function. In Alzheimer's disease and other types of dementia, there is significant damage to the blood vessels in the brain. This study will test whether changes in brain activity and function with the loss of estrogen are related to changes in vascular function. The investigators will measure vascular function using ultrasound, and brain activity using MRI scans in women who are enrolled in the Females, Aging, Metabolism and Exercise (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either take a medication to decrease their estrogen levels, or a placebo. This sub-study may provide new information about how estrogen affects vascular function and cognitive function, and lead to new ways to prevent or delay cognitive impairment or dementia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprolide acetate | Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study. |
| DRUG | Estradiol | Climara transdermal patch 0.075mg/day applied weekly months 6-9 |
| DRUG | Medroxyprogesterone | Provera 5mg tablets once daily by mouth for 12 days beginning at week 30. |
| DRUG | Placebo | placebo |
Timeline
- Start date
- 2014-09-08
- Primary completion
- 2017-05-30
- Completion
- 2017-09-15
- First posted
- 2014-04-24
- Last updated
- 2022-01-10
- Results posted
- 2022-01-10
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02122198. Inclusion in this directory is not an endorsement.