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Menopausal Hormones and Sympathetic Activation

Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07420218
Enrollment
80
Registered
2026-02-19
Start date
2026-09-01
Completion date
2030-12-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perimenopausal Women

Brief summary

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.

Interventions

DRUGEstrogen

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.

OTHERPlacebo

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.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 58 Years
Healthy volunteers
Yes

Inclusion criteria

* Perimenopausal (based on changes in menstrual cycle) * Ages 40-58 years

Exclusion criteria

* History of CVD, blood clots, stroke * History of Cancer * History of Liver or Kidney disease * History of Neurological disease * Diabetes * BMI\>35kg/m2 * Pregnant, planning on becoming pregnant, or breast feeding * Allergy to Latex * Use of Tobacco * Hysterectomy * Blood pressure \>140/90 mmHg * Current or prior use of hormone replacement therapy (within 3 mo)

Design outcomes

Primary

MeasureTime frameDescription
sympathetic nerve activityon day 6-8 of the hormone treatmentSympathetic 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).

Secondary

MeasureTime frameDescription
BOLD fMRIon day 6-8 of the hormone treatmentfunctional connectivity

Contacts

CONTACTMegan Wenner, PhD
mwenner@udel.edu13028317343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026