Estrogen Deficiency on Cardiovascular Risk

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06369363
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Diseases
  • Postmenopausal Symptoms

Eligibility Criteria

Sex
FEMALE
Age
54 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Subjects will be assigned to 1 week of transdermal placebo patch.
  • Estradiol — DRUG
    Subjects will be assigned to 1 week of transdermal estradiol (0.05 mg/day) patch.

Study Details

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.

Key Dates

First listed
Apr 17, 2024
Start date
Sep 30, 2026
Status verified
Nov 2025
Primary completion
Sep 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
  • Experimental: Estradiol

Primary Outcome Measure

Red blood cell flux [ Time Frame: Recorded continuously for up to 4 hours during the study visit ]

Central Contacts

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