Menopause
Conditions
Brief summary
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).
Detailed description
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.
Interventions
Estradiol/Norethindrone acetate 1mg/0.5 mg
DRUGPlacebo
inactive ingredient
Sponsors
Gretchen Wells
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.
Exclusion criteria
* History of hysterectomy, oophorectomy or both * History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis * History of bone disease including non-traumatic vertebral fractures on radiography * Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C \>8, uncontrolled hypertension defined as a systolic blood pressure \>160 mmHg, awaiting organ transplant) * Previous or current cancer, excluding basal cell carcinoma * Previous or current thromboembolic disease * Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC) * Current or previous use of HRT within the past 3 months * Current or recent (\<12 months) substance abuse, including tobacco use * No drug interactions with HRT * No racial or ethnic groups will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Function Assessed by Echocardiography | Baseline and 12 weeks | Change in diastolic function as assessed by echocardiography from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Level Assessed by Duke Activity Status Index (DASI) | Baseline and 12 weeks | 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. |
| Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS) | Baseline and 12 weeks | 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. |
| B-type Natriuretic Peptide (BNP) Levels | Baseline and 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| Placebo Inert ingredients by mouth oral daily for 12 weeks
Placebo: inactive ingredient | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Hormone Replacement Therapy | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Diastolic Function Assessed by Echocardiography
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Population: 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.
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.
Time frame: Baseline and 12 weeks
Population: 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.
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.
Time frame: Baseline and 12 weeks
Population: 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.
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.
Time frame: Baseline and 12 weeks
Population: 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.