Placebo
DrugSubjects will be assigned to 1 week of transdermal placebo patch.
NCT Number: NCT06369363
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.
Trial opening soon.
Get Notified54 year–75 year
Female
Interventional
Early Phase 1
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be assigned to 1 week of transdermal placebo patch.
Subjects will be assigned to 1 week of transdermal estradiol (0.05 mg/day) patch.
Time frame: Recorded continuously for up to 4 hours during the study visit
Percentage relative to the maximum flux level
Time frame: Recorded continuously for up to 4 hours during the study visit
Calculated from the systolic and diastolic blood pressure
Time frame: Upon participants' arrival to the first study visit up to 5 minutes
Measured by ELISA kits
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
Time frame: Upon participants' arrival to the first study visits up to 5 minutes
Measured by ELISA kits
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
Time frame: Upon participants' arrival to the first study visits up to 5 minutes
Measured by ELISA kits
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
Time frame: Upon participants' arrival to the first study visits up to 5 minutes
Measured by ELISA kits
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
Contact information is provided by the study sponsor or research team.
Milton S. Hershey Medical Center
Other
Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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