ClinicalTrials.gg
Not yet recruitingNCT07420218Updated Mar 27, 2026

Menopausal Hormones and Sympathetic Activation

A Phase 4 interventional study of Estrogen and Placebo in Perimenopausal Women, sponsored by University of Delaware. Not yet recruiting. Open to female participants aged 40 Years to 58 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by University of Delaware · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years to 58 Years
Sex
Female
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Study 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.

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Conditions studied

  • Perimenopausal Women
03

In context

Lead sponsor

University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 58 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of CVD, blood clots, stroke
  • History of Cancer
  • History of Liver or Kidney disease
  • History of Neurological disease
  • Diabetes
  • >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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Estrogen

    Drug: Estrogen

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • 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.

06

What researchers measure

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).

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

Secondary outcomes

  1. BOLD fMRI

    functional connectivity

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

Other outcomes

  1. Adrenergic Receptor Control of Vascular Function

    changes in cutaneous vascular conductance during norepinephrine perfusions with and without beta blockade.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Jun 2030, 45 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2025
First posted
Feb 19, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Jun 1, 2030
CompletionEst.
Dec 31, 2030
Last update
Mar 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07420218
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jun 1, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Mar 27, 2026

Study contacts

Megan Wenner, PhD
Contact
mwenner@udel.edu
13028317343

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Estrogens

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