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Not yet recruiting NCT07420218

Menopausal Hormones and Sympathetic Activation

Phase IV Interventional Perimenopausal Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Estrogen, Placebo.
Who it may be relevant to
Registry conditions: Perimenopausal Women. Basic parameters: 40 years — 58 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • sympathetic nerve activity [Time frame: on day 6-8 of the hormone treatment]
Secondary outcome measures (1)
  • BOLD fMRI [Time frame: on day 6-8 of the hormone treatment]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07420218 · 2395015 · R01AG092632

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗