Perimenopausal WomenPhase 4NCT07420218
Menopausal Hormones and Sympathetic Activation
A Phase 4 study testing Estrogen in people with Perimenopausal Women, run by University of Delaware.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Women
- What is being tested?
- Estrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Perimenopausal (based on changes in menstrual cycle)
- Ages 40-58 years
Who cannot join
- History of CVD, blood clots, stroke
- History of Cancer
- History of Liver or Kidney disease
- History of Neurological disease
- Diabetes
- BMI>35kg/m2
Show all 12Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Perimenopausal Women
- Being tested
- Estrogen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Estrogen | Experimental | Not described Receives: Drug: Estrogen |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: on day 6-8 of the hormone treatment
Secondary outcomes (1)
BOLD fMRI
functional connectivity
Measured: on day 6-8 of the hormone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420218
- Sponsor's protocol ID
- 2395015
- Other IDs
- R01AG092632
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women
- ClinicalTrials.gov ID
- NCT07420218
- Acronym / sponsor ID
- 2395015
- Conditions
- Perimenopausal Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen | Experimental | Drug: Estrogen |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Perimenopausal (based on changes in menstrual cycle)
- Ages 40-58 years
Key exclusion criteria (12 listed)
- History of CVD, blood clots, stroke
- History of Cancer
- History of Liver or Kidney disease
- History of Neurological disease
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstrogenEstradiol 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. | Drug | Estrogen |
| PlaceboAll 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 |
Primary outcome
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).
1 secondary outcome
BOLD fMRI
Time frame: on day 6-8 of the hormone treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estrogen in people with Perimenopausal Women, run by University of Delaware.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Wenner, PhD (13028317343, mwenner@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sympathetic nerve activity (time frame: on day 6-8 of the hormone treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.