Menopausal Hormones and Sympathetic Activation

NCT07420218 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: 2395015R01AG092632
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perimenopausal Women

Outcome Measures

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).

  on day 6-8 of the hormone treatment

Secondary Outcomes (1)

• BOLD fMRI

  on day 6-8 of the hormone treatment

Other Outcomes (1)

• Adrenergic Receptor Control of Vascular Function

  on day 6-8 of the hormone treatment

Study Arms (2)

Estrogen

EXPERIMENTAL

Drug: Estrogen

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

Estrogen

Placebo OTHER

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

Eligibility Criteria

• Age: 40 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Delaware: lead

MeSH Terms

Interventions

Estrogens

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Megan Wenner, PhD

CONTACT

13028317343; mwenner@udel.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: February 19, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share