Trial Outcomes & Findings for Aging and Estrogen on Cortical Function (NCT NCT01268046)
NCT ID: NCT01268046
Last Updated: 2018-08-22
Results Overview
Change in extracted beta coefficients of the blood oxygen level dependent (BOLD) signal response to a cognitive task (N-back) in the DLPFC (x,y,z coordinates = -34 44 16) from baseline to 1 month as a function of aging and estrogen (young vs older and estrogen vs placebo). A positive change indicates an increase in oxygen utilization (inferring increased neuronal functioning) between baseline and treatment during the cognitive task, while a negative change indicates a decrease in oxygen utilization between baseline and treatment during the cognitive task.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
baseline to 1 month
Results posted on
2018-08-22
Participant Flow
Participant milestones
| Measure |
Young Postmenopausal Women - Estrogen
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Estrogen
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
|
Young Postmenopausal Women - Placebo
1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Placebo
1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in older postmenopausal women
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
8
|
8
|
|
Overall Study
COMPLETED
|
12
|
9
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Young Postmenopausal Women - Estrogen
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Estrogen
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
|
Young Postmenopausal Women - Placebo
1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Placebo
1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in older postmenopausal women
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Aging and Estrogen on Cortical Function
Baseline characteristics by cohort
| Measure |
Young Postmenopausal Women - Estrogen
n=12 Participants
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Estrogen
n=9 Participants
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
|
Younger Postmenopausal Women - Placebo
n=7 Participants
1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Placebo
n=7 Participants
1 placebo capsule administered daily for one month OR 1 placebo patch with patch change every 84 hr for one month in older postmenopausal women
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
51.9 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 1.1 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 1.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to 1 monthPopulation: all young and older postmenopausal women who completed one month of placebo or estrogen and in whom structural and functional MRI data were of significant quality for analysis.
Change in extracted beta coefficients of the blood oxygen level dependent (BOLD) signal response to a cognitive task (N-back) in the DLPFC (x,y,z coordinates = -34 44 16) from baseline to 1 month as a function of aging and estrogen (young vs older and estrogen vs placebo). A positive change indicates an increase in oxygen utilization (inferring increased neuronal functioning) between baseline and treatment during the cognitive task, while a negative change indicates a decrease in oxygen utilization between baseline and treatment during the cognitive task.
Outcome measures
| Measure |
Young Postmenopausal Women - Estrogen
n=12 Participants
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Estrogen
n=9 Participants
1 oral capsule (1 mg estradiol) administered daily for one month OR 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
|
Young Postmenopausal Women - Placebo
n=7 Participants
1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Placebo
n=7 Participants
1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
|---|---|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC)
|
455.8 linear beta extractions
Standard Error 164.3
|
-214.4 linear beta extractions
Standard Error 90.1
|
-348.1 linear beta extractions
Standard Error 215.3
|
90.1 linear beta extractions
Standard Error 215.3
|
Adverse Events
Young Postmenopausal Women - Estrogen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Older Postmenopausal Women - Estrogen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Young Postmenopausal Women - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Older Postmenopausal Women - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Young Postmenopausal Women - Estrogen
n=12 participants at risk
1 oral capsule (1 mg estradiol) administered daily for one month OR : 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Estrogen
n=9 participants at risk
1 oral capsule (1 mg estradiol) administered daily for one month OR : 1 transdermal estrogen patch (50 mcg/day) with patch change every 84 hr for one month in older postmenopausal women
|
Young Postmenopausal Women - Placebo
n=7 participants at risk
1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
Older Postmenopausal Women - Placebo
n=7 participants at risk
1 placebo capsule administered daily for one month OR 1 transdermal placebo patch with patch change every 84 hr for one month in younger postmenopausal women
|
|---|---|---|---|---|
|
Psychiatric disorders
anxiety
|
0.00%
0/12 • 4 months
|
0.00%
0/9 • 4 months
|
0.00%
0/7 • 4 months
|
14.3%
1/7 • Number of events 1 • 4 months
|
|
Skin and subcutaneous tissue disorders
urticaria
|
8.3%
1/12 • Number of events 1 • 4 months
|
0.00%
0/9 • 4 months
|
0.00%
0/7 • 4 months
|
0.00%
0/7 • 4 months
|
|
Nervous system disorders
light headed
|
0.00%
0/12 • 4 months
|
11.1%
1/9 • Number of events 1 • 4 months
|
0.00%
0/7 • 4 months
|
0.00%
0/7 • 4 months
|
|
Musculoskeletal and connective tissue disorders
twisted knee
|
8.3%
1/12 • Number of events 1 • 4 months
|
0.00%
0/9 • 4 months
|
14.3%
1/7 • Number of events 1 • 4 months
|
0.00%
0/7 • 4 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/12 • 4 months
|
11.1%
1/9 • Number of events 1 • 4 months
|
0.00%
0/7 • 4 months
|
0.00%
0/7 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place