Trial Outcomes & Findings for Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study (NCT NCT00600106)
NCT ID: NCT00600106
Last Updated: 2019-04-24
Results Overview
Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater ischemia.
COMPLETED
NA
37 participants
Baseline
2019-04-24
Participant Flow
Participant milestones
| Measure |
Hormone Replacement Therapy
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
1 mg placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Hormone Replacement Therapy
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
1 mg placebo.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
Baseline characteristics by cohort
| Measure |
Hormone Replacement Therapy
n=18 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=19 Participants
1 mg placebo.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9 • n=5 Participants
|
59 years
STANDARD_DEVIATION 7 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Race/Ethnicity, Customized
Nonwhite
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Education
High school or less
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Education
College
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Current HT use prior to entry
Current HT use prior to entry
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Current HT use prior to entry
No HT prior to entry
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
History of Hypertension
Hypertension
|
5 participants
n=5 Participants
|
14 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
History of Hypertension
Normal blood pressure
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
History of Diabetes
History of Diabetes
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
History of Diabetes
No Diabetes
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
History of Dyslipidemia
Dyslipidemia
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
History of Dyslipidemia
Normal values
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Current Smoking
Smoking
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Current Smoking
No smoking
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Total Cholesterol
|
195 mg/dl
STANDARD_DEVIATION 47 • n=5 Participants
|
205 mg/dl
STANDARD_DEVIATION 39 • n=7 Participants
|
200 mg/dl
STANDARD_DEVIATION 43 • n=5 Participants
|
|
HDL-Cholesterol
|
48 mg/dl
STANDARD_DEVIATION 16 • n=5 Participants
|
54 mg/dl
STANDARD_DEVIATION 9 • n=7 Participants
|
51 mg/dl
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
LDL-Cholesterol
|
120 mg/dl
STANDARD_DEVIATION 51 • n=5 Participants
|
124 mg/dl
STANDARD_DEVIATION 38 • n=7 Participants
|
122 mg/dl
STANDARD_DEVIATION 44.5 • n=5 Participants
|
|
Triglycerides
|
132 mg/dl
STANDARD_DEVIATION 92 • n=5 Participants
|
134 mg/dl
STANDARD_DEVIATION 64 • n=7 Participants
|
133 mg/dl
STANDARD_DEVIATION 78 • n=5 Participants
|
|
Systolic Blood Pressure
|
130 mmHg
STANDARD_DEVIATION 18 • n=5 Participants
|
136 mmHg
STANDARD_DEVIATION 18 • n=7 Participants
|
133 mmHg
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Diastolic Blood Pressure
|
76 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
78 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
77 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Pulse
|
68 beats per minute
STANDARD_DEVIATION 8 • n=5 Participants
|
76 beats per minute
STANDARD_DEVIATION 11 • n=7 Participants
|
72 beats per minute
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Fasting Blood Sugar
|
93 mg/dl
STANDARD_DEVIATION 17 • n=5 Participants
|
94 mg/dl
STANDARD_DEVIATION 20 • n=7 Participants
|
93.5 mg/dl
STANDARD_DEVIATION 18.5 • n=5 Participants
|
|
Body Mass Index
|
31 kg/m^2
STANDARD_DEVIATION 9 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 7 • n=7 Participants
|
31 kg/m^2
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Waist circumference
|
92 cm.
STANDARD_DEVIATION 17 • n=5 Participants
|
93 cm.
STANDARD_DEVIATION 15 • n=7 Participants
|
92.5 cm.
STANDARD_DEVIATION 16 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Among the 35 women, 28 baseline and 26 exit MRS results were technically adequate for spectral analyses with rest, handgrip exercise, and recovery spectra. A total of 24 women (13 drug, 11 placebo) had both baseline and exit P31's.
Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater ischemia.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=15 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=13 Participants
1 mg placebo.
|
|---|---|---|
|
Inducible Myocardial Ischemia
|
-13.8 percent changed in PCR/ATP ratio
Standard Deviation 24.2
|
-7.0 percent changed in PCR/ATP ratio
Standard Deviation 22.8
|
PRIMARY outcome
Timeframe: BaselinePopulation: Brachial artery reactivity testing at baseline by treatment
Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of endothelial dysfunction. Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\].
Outcome measures
| Measure |
Hormone Replacement Therapy
n=16 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=18 Participants
1 mg placebo.
|
|---|---|---|
|
Endothelial Dysfunction (FMD)
|
8.2 percentage of pre-stimulus diameter
Standard Deviation 7.8
|
8.8 percentage of pre-stimulus diameter
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Brachial artery reactivity testing at study exit by treatment
Endothelial dysfunction refers to altered vasoactive, anticoagulant, and anti-inflammatory properties of endothelium, and dysregulated vascular growth remodeling that results from a loss of nitric oxide (NO) bioactivity in the endothelium. Brachial Artery Reactivity Testing (BART), high-frequency ultrasonographic imaging of the brachial artery, evaluates flow-mediated vasodilation (FMD), an endothelium-dependent function. The technique provokes the release of nitric oxide, resulting in vasodilation that can be quantitated as an index of vasomotor function. Flow-mediated vasodilation is typically expressed as the change in post-stimulus diameter as a percentage of the baseline diameter \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\].
Outcome measures
| Measure |
Hormone Replacement Therapy
n=15 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=16 Participants
1 mg placebo.
|
|---|---|---|
|
Endothelial Dysfunction (FMD)
|
8.8 percentage of pre-stimulus diameter
Standard Deviation 5.3
|
7.3 percentage of pre-stimulus diameter
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Among the 35 women, 28 baseline and 26 exit MRS results were technically adequate for spectral analyses with rest, handgrip exercise, and recovery spectra. A total of 24 women (13 drug, 11 placebo) had both baseline and exit P31's.
Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater ischemia.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=14 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=12 Participants
1 mg placebo.
|
|---|---|---|
|
Inducible Myocardial Ischemia
|
-7.7 percent change in PCR/ATP ratio
Standard Deviation 20.8
|
1.1 percent change in PCR/ATP ratio
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Exercise stress testing at baseline by treatment
Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. A MET is defined as the resting metabolic rate, that is, the amount or oxygen consumet at rest, sitting quietly in a chair, approximately 3.5 ml O2 / kg / min (1.2 kcallmin for a 70-kg person). As such, work at METs requires twice the resting metabolism or 7.0 ml O2/kg/min, and so on.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=17 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=16 Participants
1 mg placebo.
|
|---|---|---|
|
Physical Functional Disability - Functional Capacity (METs)
|
5.4 metabolism equivalents
Standard Deviation 2.6
|
5.4 metabolism equivalents
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Menopause Symptoms at baseline by treatment
Quality of life assessed by menopausal symptoms and psychological questionnaires
Outcome measures
| Measure |
Hormone Replacement Therapy
n=18 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=19 Participants
1 mg placebo.
|
|---|---|---|
|
Quality of Life - Menopause Symptoms
Hot flushes or flashing
|
89 percent of participants
|
68 percent of participants
|
|
Quality of Life - Menopause Symptoms
Poor memory
|
76 percent of participants
|
53 percent of participants
|
|
Quality of Life - Menopause Symptoms
Change in sexual desire
|
50 percent of participants
|
37 percent of participants
|
|
Quality of Life - Menopause Symptoms
Vaginal dryness
|
44 percent of participants
|
58 percent of participants
|
|
Quality of Life - Menopause Symptoms
Avoiding intimacy
|
39 percent of participants
|
37 percent of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Menopause Symptoms at exit by treatment
Quality of life assessed by menopausal symptoms and psychological questionnaires
Outcome measures
| Measure |
Hormone Replacement Therapy
n=17 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=18 Participants
1 mg placebo.
|
|---|---|---|
|
Quality of Life - Menopause Symptoms
Poor memory
|
59 percent of participants
|
78 percent of participants
|
|
Quality of Life - Menopause Symptoms
Change in sexual desire
|
35 percent of participants
|
67 percent of participants
|
|
Quality of Life - Menopause Symptoms
Hot flushes or flashing
|
41 percent of participants
|
89 percent of participants
|
|
Quality of Life - Menopause Symptoms
Vaginal dryness
|
35 percent of participants
|
67 percent of participants
|
|
Quality of Life - Menopause Symptoms
Avoiding intimacy
|
24 percent of participants
|
56 percent of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: SF-36 scale at baseline by treatment
Quality of life assessed by cardiac symptoms and psychological questionnaires (SF 36 scale - Short Form Health Survey) The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=18 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=19 Participants
1 mg placebo.
|
|---|---|---|
|
Quality of Life - Health Survey
Physical functioning
|
60.8 units on a scale
Standard Deviation 27.5
|
43.8 units on a scale
Standard Deviation 27.4
|
|
Quality of Life - Health Survey
Role-physical
|
54.2 units on a scale
Standard Deviation 41.3
|
37.3 units on a scale
Standard Deviation 40.2
|
|
Quality of Life - Health Survey
Role-emotional
|
70.3 units on a scale
Standard Deviation 42.6
|
66.7 units on a scale
Standard Deviation 41.6
|
|
Quality of Life - Health Survey
Bodily pain
|
53.3 units on a scale
Standard Deviation 21.4
|
42.1 units on a scale
Standard Deviation 17.4
|
|
Quality of Life - Health Survey
General health
|
55.4 units on a scale
Standard Deviation 19.4
|
57.4 units on a scale
Standard Deviation 15.1
|
|
Quality of Life - Health Survey
Mental health
|
66.7 units on a scale
Standard Deviation 20.6
|
65.7 units on a scale
Standard Deviation 19.9
|
|
Quality of Life - Health Survey
Vitality
|
35.6 units on a scale
Standard Deviation 23.1
|
42.9 units on a scale
Standard Deviation 20.4
|
|
Quality of Life - Health Survey
Social functioning
|
59.4 units on a scale
Standard Deviation 14.7
|
53.2 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: SF-36 scale at exit by treatment
Quality of life assessed by cardiac symptoms and psychological questionnaires (SF 36 scale - Short Form Health Survey) The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=17 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=18 Participants
1 mg placebo.
|
|---|---|---|
|
Quality of Life - Health Survey
Role-physical
|
58.8 units on a scale
Standard Deviation 37.4
|
25.0 units on a scale
Standard Deviation 33.2
|
|
Quality of Life - Health Survey
Vitality
|
35.6 units on a scale
Standard Deviation 24.5
|
41.2 units on a scale
Standard Deviation 18.0
|
|
Quality of Life - Health Survey
Physical functioning
|
59.4 units on a scale
Standard Deviation 23.5
|
44.4 units on a scale
Standard Deviation 29.5
|
|
Quality of Life - Health Survey
Role-emotional
|
76.5 units on a scale
Standard Deviation 34.9
|
66.7 units on a scale
Standard Deviation 39.6
|
|
Quality of Life - Health Survey
Bodily pain
|
54.5 units on a scale
Standard Deviation 23.6
|
41.5 units on a scale
Standard Deviation 21.6
|
|
Quality of Life - Health Survey
General health
|
55.2 units on a scale
Standard Deviation 19.7
|
57.2 units on a scale
Standard Deviation 15.8
|
|
Quality of Life - Health Survey
Mental health
|
66.4 units on a scale
Standard Deviation 19.6
|
69.3 units on a scale
Standard Deviation 18.8
|
|
Quality of Life - Health Survey
Social functioning
|
59.4 units on a scale
Standard Deviation 16.0
|
56.1 units on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Exit at 12 weeksPopulation: Exercise stress testing at exit (12 weeks) by treatment
Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. A MET is defined as the resting metabolic rate, that is, the amount or oxygen consumet at rest, sitting quietly in a chair, approximately 3.5 ml O2 / kg / min (1.2 kcallmin for a 70-kg person). As such, work at METs requires twice the resting metabolism or 7.0 ml O2/kg/min, and so on.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=14 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=13 Participants
1 mg placebo.
|
|---|---|---|
|
Physical Functional Disability - Functional Capacity (METs)
|
6.1 metabolism equivalents
Standard Deviation 2.4
|
5.4 metabolism equivalents
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Exercise stress testing at baseline by treatment
Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=17 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=16 Participants
1 mg placebo.
|
|---|---|---|
|
Physical Functional Disability - Functional Capacity (Metabolism Equivalents)
|
6.1 metabolism equivalents
Standard Deviation 3.0
|
5.8 metabolism equivalents
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Exit (12 weeks)Population: Exercise stress testing at exit (12 weeks) by treatment
Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain.
Outcome measures
| Measure |
Hormone Replacement Therapy
n=14 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=13 Participants
1 mg placebo.
|
|---|---|---|
|
Physical Functional Disability - Functional Capacity (Metabolism Equivalents)
|
6.1 metabolism equivalents
Standard Deviation 2.4
|
5.4 metabolism equivalents
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Exercise stress testing at baseline by treatment
Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. In electrocardiography, the ST segment connects the QRS complex and the T wave and has duration of 80 to 120 ms. It should be essentially level with the PR and TP segment. The normal ST segment has a slight upward concavity. Flat, downsloping, or depressed ST segment may indicate coronary ishcemia. Positive treadmill exercise stress test (\>1.0 mm horizontal / downsloping or \>1.5 upsloping ST segment depression measured 0.08 msec after the J point).
Outcome measures
| Measure |
Hormone Replacement Therapy
n=17 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=16 Participants
1 mg placebo.
|
|---|---|---|
|
Physical Functional Disability - Functional Capacity (Exercise Induced ST Segment Depression)
|
-0.79 mm
Standard Deviation 0.78
|
-0.79 mm
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Exit (12 weeks)Population: Exercise stress testing at exit (12 weeks) by treatment
Physical functional disability measured by exercise stress testing. Functional capacity was measured as metabolism equivalents (METs), exercise duration, and exercise-induced chest pain. In electrocardiography, the ST segment connects the QRS complex and the T wave and has duration of 80 to 120 ms. It should be essentially level with the PR and TP segment. The normal ST segment has a slight upward concavity. Flat, downsloping, or depressed ST segment may indicate coronary ishcemia. Positive treadmill exercise stress test (\>1.0 mm horizontal / downsloping or \>1.5 upsloping ST segment depression measured 0.08 msec after the J point).
Outcome measures
| Measure |
Hormone Replacement Therapy
n=14 Participants
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=13 Participants
1 mg placebo.
|
|---|---|---|
|
Physical Functional Disability - Functional Capacity (Stress Induced ST Segment Depression)
|
-1.05 mm
Standard Deviation 0.98
|
-0.63 mm
Standard Deviation 0.29
|
Adverse Events
Hormone Replacement Therapy
Placebo
Serious adverse events
| Measure |
Hormone Replacement Therapy
n=18 participants at risk
Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE).
|
Placebo
n=19 participants at risk
1 mg placebo.
|
|---|---|---|
|
Cardiac disorders
Hospitalization for angina and a stroke
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
|
Hepatobiliary disorders
Hospitalizaton for biliary colic
|
5.6%
1/18 • Number of events 1 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place