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NCT06369363 | Not yet recruiting | Postmenopausal Symptoms

Estrogen Deficiency on Cardiovascular Risk
Sponsor:

Milton S. Hershey Medical Center

Information provided by (Responsible Party):

l u Q in

Brief Summary:

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.

Condition or disease

Postmenopausal Symptoms

Cardiovascular Diseases

Intervention/treatment

Placebo

Estradiol

Phase

Early Phase 1

Detailed 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.

Study Type : Interventional
Estimated Enrollment : 20 participants
Masking : Triple
Primary Purpose : Basic Science
Official Title : Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines
Actual Study Start Date : September 2025
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : November 2027
Arm Intervention/treatment

Placebo Comparator: Placebo

Drug: Placebo

Experimental: Estradiol

Drug: Estradiol
Ages Eligible for Study: 54 Years to 75 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.
Estrogen Deficiency on Cardiovascular Risk

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Estrogen Deficiency on Cardiovascular Risk

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