Health TrialsbyHealthPanel

Menopausal Hormones and Sympathetic Activation

ConditionPerimenopausal Women
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40-58
SponsorUniversity of Delaware

About this trial

The purpose of this study is to understand how changes in menopausal hormones like estradiol and follicle-stimulating hormone (FSH) impact sympathetic nervous system function. To do so, the investigators will use a medication to control the production of estradiol and FSH, and in some participants, add-back estradiol to isolate its effects. The investigators will measure sympathetic activation centrally (in the brain using MRI), peripherally in the nervous system, and also examine adrenergic receptor mediated control of vascular function.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Perimenopausal (based on changes in menstrual cycle)

Ages 40-58 years

Disqualifiers

History of CVD, blood clots, stroke

History of Cancer

History of Liver or Kidney disease

History of Neurological disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Estrogen

    Drug

    Estradiol patch (0.1mg) All women will use a GnRH antagonist for 8 days. Some women will receive an estradiol patch for to wear on days 3-8, whereas other women will receive a placebo patch to wear on days 3-8. Measurements of sympathetic activation will occur on days 6-8.

  • Placebo

    Other intervention

    All women will use a GnRH antagonist for 8 days. Some women will receive an estradiol patch for to wear on days 3-8, whereas other women will receive a placebo patch to wear on days 3-8. Measurements of sympathetic activation will occur on days 6-8.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: EstrogenExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

sympathetic nerve activity

Sympathetic nerve activity will be measured using a technique called microneurography and reported as burst frequency (number of bursts per minute) and burst area (height / size of bursts).

Time frame
on day 6-8 of the hormone treatment

Secondary outcomes

1

BOLD fMRI

functional connectivity

Time frame
on day 6-8 of the hormone treatment

Other outcomes

1

Adrenergic Receptor Control of Vascular Function

changes in cutaneous vascular conductance during norepinephrine perfusions with and without beta blockade.

Time frame
on day 6-8 of the hormone treatment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Delaware

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: