Trial · NCT00600106
Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
NCT00600106, Not applicable, Completed, Cedars-Sinai Medical Center; results first posted 2017-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study. Trials, record NCT00600106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600106
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
- NCT number
- NCT00600106
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 37 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- Conditions
- Myocardial Ischemia
- Interventions
- 1/10 NA/EE, Placebo
- First posted
- 2008-01-24
- Last updated
- 2019-04-24
- Results first posted
- 2017-12-19
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Inducible Myocardial Ischemia | Baseline | 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. |
| Primary | Endothelial Dysfunction (FMD) | Baseline | 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 \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\]. |
| Primary | Endothelial Dysfunction (FMD) | 12 weeks | 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 \[diameter after cuff deflation - baseline diameter / baseline diameter) x 100\]. |
| Primary | Inducible Myocardial Ischemia | 12 weeks | 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. |
| Secondary | Physical Functional Disability - Functional Capacity (METs) | Baseline | 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. |
| Secondary | Quality of Life - Menopause Symptoms | Baseline | Quality of life assessed by menopausal symptoms and psychological questionnaires |
| Secondary | Quality of Life - Menopause Symptoms | 12 weeks | Quality of life assessed by menopausal symptoms and psychological questionnaires |
| Secondary | Quality of Life - Health Survey | Baseline | 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. |
| Secondary | Quality of Life - Health Survey | 12 weeks | 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. |
| Secondary | Physical Functional Disability - Functional Capacity (METs) | Exit at 12 weeks | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Inducible Myocardial Ischemia | Baseline | 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. | percent changed in PCR/ATP ratio | MEAN |
| SECONDARY | Physical Functional Disability - Functional Capacity (METs) | Baseline | Exercise stress testing at baseline by treatment | metabolism equivalents | MEAN |
| PRIMARY | Endothelial Dysfunction (FMD) | Baseline | Brachial artery reactivity testing at baseline by treatment | percentage of pre-stimulus diameter | MEAN |
| SECONDARY | Quality of Life - Menopause Symptoms | Baseline | Menopause Symptoms at baseline by treatment | percent of participants | NUMBER |
| PRIMARY | Endothelial Dysfunction (FMD) | 12 weeks | Brachial artery reactivity testing at study exit by treatment | percentage of pre-stimulus diameter | MEAN |
| SECONDARY | Quality of Life - Menopause Symptoms | 12 weeks | Menopause Symptoms at exit by treatment | percent of participants | NUMBER |
| SECONDARY | Quality of Life - Health Survey | Baseline | SF-36 scale at baseline by treatment | units on a scale | MEAN |
| SECONDARY | Quality of Life - Health Survey | 12 weeks | SF-36 scale at exit by treatment | units on a scale | MEAN |
| PRIMARY | Inducible Myocardial Ischemia | 12 weeks | 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. | percent change in PCR/ATP ratio | MEAN |
| SECONDARY | Physical Functional Disability - Functional Capacity (METs) | Exit at 12 weeks | Exercise stress testing at exit (12 weeks) by treatment | metabolism equivalents | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Inducible Myocardial Ischemia | Hormone Replacement Therapy | -13.8 | Standard Deviation 24.2 | percent changed in PCR/ATP ratio | |
| Inducible Myocardial Ischemia | Placebo | -7.0 | Standard Deviation 22.8 | percent changed in PCR/ATP ratio | |
| Physical Functional Disability - Functional Capacity (METs) | Hormone Replacement Therapy | 5.4 | Standard Deviation 2.6 | metabolism equivalents | |
| Physical Functional Disability - Functional Capacity (METs) | Placebo | 5.4 | Standard Deviation 1.8 | metabolism equivalents | |
| Endothelial Dysfunction (FMD) | Hormone Replacement Therapy | 8.2 | Standard Deviation 7.8 | percentage of pre-stimulus diameter | |
| Endothelial Dysfunction (FMD) | Placebo | 8.8 | Standard Deviation 7.3 | percentage of pre-stimulus diameter | |
| Quality of Life - Menopause Symptoms | Hormone Replacement Therapy | Hot flushes or flashing | 89 | percent of participants | |
| Quality of Life - Menopause Symptoms | Placebo | Hot flushes or flashing | 68 | percent of participants | |
| Quality of Life - Menopause Symptoms | Hormone Replacement Therapy | Poor memory | 76 | percent of participants | |
| Quality of Life - Menopause Symptoms | Placebo | Poor memory | 53 | percent of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hormone Replacement Therapy | 18 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | COMPLETED | Hormone Replacement Therapy | 17 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Hormone Replacement Therapy | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hospitalization for angina and a stroke | Cardiac disorders | Hormone Replacement Therapy | 1 | 18 | 1 |
| serious | Hospitalization for angina and a stroke | Cardiac disorders | Placebo | 0 | 19 | 0 |
| serious | Hospitalizaton for biliary colic | Hepatobiliary disorders | Hormone Replacement Therapy | 1 | 18 | 1 |
| serious | Hospitalizaton for biliary colic | Hepatobiliary disorders | Placebo | 0 | 19 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hormone Replacement Therapy | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Hormone Replacement Therapy | 0 | 18 |
| Total, other adverse events | Placebo | 0 | 19 |
| Total, serious adverse events | Hormone Replacement Therapy | 2 | 18 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers42
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Hormone Replacement Therapy vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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