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NCT Number: NCT07420218

Menopausal Hormones and Sympathetic Activation

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.

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Key information

Conditions

Perimenopausal Women

Age range

40 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. BOLD fMRI

    Time frame: on day 6-8 of the hormone treatment

    functional connectivity

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Wenner, PhD

CONTACT

[email protected]

13028317343

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 19, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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