Menopausal Hormones and Sympathetic Activation

March 25, 2026 updated by: University of Delaware

Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
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.
Experimental: Estrogen
Drug: Estrogen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sympathetic nerve activity
Time Frame: on day 6-8 of the hormone treatment
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).
on day 6-8 of the hormone treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD fMRI
Time Frame: on day 6-8 of the hormone treatment
functional connectivity
on day 6-8 of the hormone treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adrenergic Receptor Control of Vascular Function
Time Frame: on day 6-8 of the hormone treatment
changes in cutaneous vascular conductance during norepinephrine perfusions with and without beta blockade.
on day 6-8 of the hormone treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2395015
  • R01AG092632 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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