Cardiovascular Disease (CVD) Clinical Trial
Official title:
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
Verified date | January 2024 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether low estrogen levels in young women with hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for cardiovascular disease. For this study, the investigators will measuring vascular function and immune markers on: - young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low estrogen) - young women with regular menstrual cycles not on hormone therapy. - recently menopausal women (<3 years from final menstrual period) not on hormone therapy. Premenopausal HypoE participants will then be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if estrogen improves vascular and immune function.
Status | Completed |
Enrollment | 29 |
Est. completion date | February 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: For premenopausal Hypo E and normal control women, inclusions include: - Premenopausal currently not on hormone therapy, - English speaking (for the purposes of complete psychosocial assessment) - able to give informed consent - a gynecological age (age since menarche) > 10 and < 25 years, and chronological age > 18 years - Within 90-110% of ideal body weight as determined by the 1983 Metropolitan Height and weight table for women - All participants with hypothalamic amenorrhea will be diagnosed based on exclusion of other etiologies for their amenorrhea, including pregnancy, thyroid dysfunction, hyperprolactinemia, premature ovarian insufficiency, and polycystic ovary disease For recently menopausal women inclusions include: - Follicle stimulating hormones (FSH) >30 and 12 months of amenorrhea, within 3 years of final menstrual period with natural menopausal not on hormone therapy - English speaking - Able to give informed consent - Within 90-110% of ideal body weight Exclusion Criteria: For premenopausal Hypo E and normal control women exclusions include: - Smoking - Hypertension - Hyperlipidemia - Diabetes - Medications including psychotropic or illicit drugs, medical, neurological - Ophthalmologic disease except acuity problems - Major Axis I disorder other than depression - Pregnancy in the last 12 months and/or lactating in the last 6 months - Current use of hormone contraceptive or any estrogen or progestin therapy For HypoE women, exclusion criteria include: - Allergy to adhesive or tape For recently menopausal women exclusions also include: - Previous or current use of hormone therapy, estrogen or progestin - Surgical or chemotherapy induced menopause - Premature ovarian failure |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Barbra Streisand Women's Heart Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of change of peripheral arterial tonometry (PAT) | PAT measured as reactive hyperemia index (RHI%) | Baseline, week 6, 12, and 14 on trial | |
Secondary | Rate of change of pulse wave analysis | SphymoCor measured as augmentation index | Baseline, week 6, 12, and 14 on trial | |
Secondary | Rate of change of pulse wave velocity | SphymoCor measured as meters/second | Baseline, week 6, 12, and 14 on trial | |
Secondary | Serum Inflammatory Markers | Baseline, week 6, 12, and 14 on trial | ||
Secondary | Hormone levels | Baseline, week 6, 12, and 14 on trial | ||
Secondary | Quality of life (questionnaire) | Short-Form Health Survey 12 | Baseline, week 6, 12, and 14 on trial | |
Secondary | Depression | Patient Health Questionnaire (PHQ-9) | Baseline, week 6, 12, and 14 on trial | |
Secondary | Sleep changes | Insomnia Severity Index | Baseline, week 6, 12, and 14 on trial | |
Secondary | Anxiety | Overall Anxiety Severity and Impairment Scale (OASIS) | Baseline, week 6, 12, and 14 on trial | |
Secondary | Stress | Cohen Perceived Stress Scale | Baseline, week 6, 12, and 14 on trial | |
Secondary | DEXA Scan | dual-energy x-ray absorptiometry (DEXA) bone mass | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02234492 -
The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients
|
Phase 4 | |
Completed |
NCT03582696 -
Carolina Heart Alliance Networking for Greater Equity
|
N/A | |
Active, not recruiting |
NCT03419325 -
A Genomic Approach for Clopidogrel in Caribbean Hispanics
|
Early Phase 1 | |
Recruiting |
NCT04315766 -
Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention
|
||
Recruiting |
NCT03938155 -
Women's Advanced Risk-assessment in Manitoba
|
||
Active, not recruiting |
NCT02697422 -
Veteran Peer Coaches Optimizing and Advancing Cardiac Health
|
N/A | |
Completed |
NCT01625845 -
Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)
|
Phase 2 | |
Completed |
NCT01605552 -
Beating the Blues for Your Heart
|
Phase 2 | |
Completed |
NCT02035826 -
A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk
|
N/A | |
Active, not recruiting |
NCT01864031 -
The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study
|
N/A | |
Completed |
NCT01299883 -
West Philadelphia Consortium Randomized Control Trial
|
N/A | |
Completed |
NCT02107053 -
The Effect of Pomegranate Juice (PJ) on Oxidative Stress Biomarkers During Treatment With IV Iron During One Dialysis Session
|
N/A | |
Not yet recruiting |
NCT06334666 -
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD.
|
N/A |