Estrogen Deficiency on Cardiovascular Risk

Penn State Health

Status and phase

Begins enrollment in 3 months

Early Phase 1

Conditions

Cardiovascular Diseases

Postmenopausal Symptoms

Treatments

Drug: Placebo

Drug: Estradiol

Study type

Interventional

Funder types

Other

Identifiers

NCT06369363

STUDY000024245

Details and patient eligibility

About

To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor.

Full description

In the United States, cardiovascular disease (CVD) is one of the major health concerns and affects approximately 6.5 million people over 40. As the number of elderly women increases, CVD becomes an increasing problem. Estrogen is cardioprotective, and the menopause condition in the aging female population induces the loss of this protective effect. There has been a dilemma for medical treatment in CVD patients with comorbidities including endometriosis or breast cancer history. Overall, these patients lose the cardioprotective effect of estrogen and increase the risk of CVD development. However, there is still little understanding regarding the mechanism for how estrogen suppression in women accelerates CVD development. The proposed studies are, therefore, the essential first step to elucidating how estrogen alters mechanisms underlying CVD and provide the preclinical data to design studies for future alternative intervention strategies for CVD patients undergoing estrogen suppression therapies.

Enrollment

20 estimated patients

Sex

Female

Ages

54 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 54-75 years
Healthy participants who are capable of giving informed consent
Classified as postmenopausal or stop having period >1year or had a full hysterectomy surgery
Any race or ethnicity
Have satisfactory history and physical exam
Free of acute medical conditions

Exclusion criteria

<54 or >75 years
Medications that could alter cardiovascular, thermoregulatory, or peripheral vascular control (e.g. Angiotensin converting enzyme inhibitors, statins, beta blockers, etc.);
Self-reported history of long-term menstrual irregularities, vaginal bleeding, or other gynecological conditions that could influence study outcomes
Use of hormone therapy during 6 months prior to study enrollment
Allergy to latex
Current smoker
Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.
Presenting with a resting blood pressure of 150/100 or higher
Contraindications to a maximal exercise test or an indication for early termination of an exercise test
Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)
Contraindications to estrogen patch: include undiagnosed vaginal bleeding; known, suspected, or history of breast cancer; known or suspected E2-sensitive neoplasm; history of deep venous thrombosis or pulmonary embolism; current or recent arterial thromboembolic disease; liver dysfunction and disease; known or suspected pregnancy.
Past/current history of venous thromboembolism, hypercoagulation or thrombopenia
Past/current history of hormone-responsive cancer
Past/current history of endometrial hyperplasia
Patient has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week.