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Enrollment goals not being met
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Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).
This preliminary, feasibility study will randomize 28 peri-menopausal women to either hormone replacement therapy or placebo for 12 weeks. Prior to randomization, each participant will undergo echocardiography, measurements of activity using the Duke Activity Status Index, measurements of quality of life and laboratory data, including b-type natriuretic peptide (BNP) measurements. Following the intervention for 12 weeks, these measurements will all be repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormone replacement therapy | Active Comparator | Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks |
|
| Placebo | Placebo Comparator | Inert ingredients by mouth oral daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol/Norethindrone acetate | Drug | Estradiol/Norethindrone acetate 1mg/0.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Function Assessed by Echocardiography | Change in diastolic function as assessed by echocardiography from baseline to 12 weeks | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Level Assessed by Duke Activity Status Index (DASI) | Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a "No" answer or awarded a fixed number of points ranging from 1.75-8 for a "Yes" answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen L Wells, MD, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
The data will be provided to participants of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hormone Replacement Therapy | Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg |
| FG001 | Placebo | Inert ingredients by mouth oral daily for 12 weeks Placebo: inactive ingredient |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hormone Replacement Therapy | Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diastolic Function Assessed by Echocardiography | Change in diastolic function as assessed by echocardiography from baseline to 12 weeks | Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality. | Posted | Baseline and 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hormone Replacement Therapy | Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks Estradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Bleeding | Reproductive system and breast disorders | Systematic Assessment | Patient was randomized on 7/6/16. She developed vaginal bleeding on 8/7/16. Vaginal bleeding ICFinformed consent form. The patient underwent evaluation by primary care provider, stopped drug, and was withdrawn from the study. |
Due to limited enrollment, there were too few participants to draw statistically meaningful conclusions from collected data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gretchen Wells, PI | University of Kentucky | gretchen.wells@uky.edu |
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| ID | Term |
|---|---|
| C418365 | estradiol, norethindrone drug combination |
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| Placebo | Drug | inactive ingredient |
|
| Baseline and 12 weeks |
| Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS) | Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates "Not true of me" and 5 indicates an answer of "mostly true". Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for "Occupational", 31 points for "Health", 28 points for "Emotional" and 15 points for "Sexual" for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time. | Baseline and 12 weeks |
| B-type Natriuretic Peptide (BNP) Levels | Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time. | Baseline and 12 weeks |
Inert ingredients by mouth oral daily for 12 weeks
Placebo: inactive ingredient
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Activity Level Assessed by Duke Activity Status Index (DASI) | Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a "No" answer or awarded a fixed number of points ranging from 1.75-8 for a "Yes" answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks. | Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality. | Posted | Baseline and 12 weeks |
|
|
| Secondary | Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS) | Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates "Not true of me" and 5 indicates an answer of "mostly true". Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for "Occupational", 31 points for "Health", 28 points for "Emotional" and 15 points for "Sexual" for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time. | Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality. | Posted | Baseline and 12 weeks |
|
|
| Secondary | B-type Natriuretic Peptide (BNP) Levels | Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time. | Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality. | Posted | Baseline and 12 weeks |
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| 0 |
| 2 |
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| 2 |
| 1 |
| 2 |
| EG001 | Placebo | Inert ingredients by mouth oral daily for 12 weeks Placebo: inactive ingredient | 0 | 2 | 0 | 2 | 0 | 2 |
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