Estrogen Deficiency on Cardiovascular Risk
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age54-75
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
<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
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugSubjects will be assigned to 1 week of transdermal placebo patch.
Estradiol
DrugSubjects will be assigned to 1 week of transdermal estradiol (0.05 mg/day) patch.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: EstradiolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Red blood cell flux
Percentage relative to the maximum flux level
Time frame
Recorded continuously for up to 4 hours during the study visit2
Mean arterial pressure (mmHg)
Calculated from the systolic and diastolic blood pressure
Time frame
Recorded continuously for up to 4 hours during the study visit3
baseline plasma TNF-α concentration (pg/ml)
Measured by ELISA kits
Time frame
Upon participants' arrival to the first study visit up to 5 minutes4
One week post-intervention plasma TNF-α concentration (pg/ml)
Measured by ELISA kits
Time frame
Upon participants' arrival to the second study visit (1 week after the first visit)Secondary outcomes
1
baseline plasma estrogen (pg/ml)
Measured by ELISA kits
Time frame
Upon participants' arrival to the first study visits up to 5 minutes2
One week post-intervention plasma estrogen (pg/ml)
Measured by ELISA kits
Time frame
Upon participants' arrival to the second study visit (1 week after the first visit)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: