MenopauseEarly Phase 1NCT06787066
Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms
A Early Phase 1 study testing Propranolol Hydrochloride and Phentolamine Injection in people with Menopause, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Propranolol Hydrochloride and Phentolamine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2025to Dec 2026
- Phase
- Early Phase 1
- 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Assigned female at birth
- 18-70 years of age
- Body mass index (BMI) <30 kg/m2
Who cannot join
- Assigned male at birth
- Pregnancy, breastfeeding
- Body mass index ≥30 kg/m2
- Oral hormonal contraception in last 6 months, history of hormone replacement therapy, oophorectomy
- Current smoking/nicotine use
- Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
Show all 12Show fewer
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
- Blood pressure ≥140/90 mmHg
- Diabetes, Polycystic ovarian syndrome
- Communication barriers
- Prescription medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Jacqueline Limberg, 573-882-2544, limbergj@missouri.edu
About this study
The investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.
- Conditions
- Menopause
- Being tested
- Propranolol Hydrochloride, Phentolamine Injection
- Keywords
- Menopause, Sympathetic nerve activity, Sympathetic transduction, Blood flow, Women's health, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Examine how IV propranolol impacts sympathetic transduction
Phentolamine InjectionDrug
Examine how IV phentolamine impacts sympathetic transduction
| Study group | Role | What they receive |
|---|---|---|
| Women | Other | Women ages 18-70 years will participate. Receives: Drug: Propranolol Hydrochloride; Drug: Phentolamine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic transduction
Assessing the relative change in blood flow (Doppler ultrasound) following an increase in sympathetic nerve activity.
Measured: 1 day (single study visit)
Secondary outcomes (2)
Blood flow
Measuring femoral artery blood flow using Doppler ultrasound.
Measured: 1 day (single study visit)
Muscle sympathetic nerve activity
Measuring the sympathetic nerve activity of the fibular nerve using a microelectrode .
Measured: 1 day (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start10 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline K Limberg, PhD, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787066
- Sponsor's protocol ID
- 2125473
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms
- ClinicalTrials.gov ID
- NCT06787066
- Acronym / sponsor ID
- 2125473
- Conditions
- Menopause
- Keywords
- Menopause, Sympathetic nerve activity, Sympathetic transduction, Blood flow, Women's health, Blood pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2025 (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 investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women | Other | Drug: Propranolol Hydrochloride, Drug: Phentolamine InjectionWomen ages 18-70 years will participate. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assigned female at birth
- 18-70 years of age
- Body mass index (BMI) <30 kg/m2
Key exclusion criteria (12 listed)
- Assigned male at birth
- Pregnancy, breastfeeding
- Body mass index ≥30 kg/m2
- Oral hormonal contraception in last 6 months, history of hormone replacement therapy, oophorectomy
- Current smoking/nicotine use
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 |
|---|---|---|
| Propranolol HydrochlorideExamine how IV propranolol impacts sympathetic transduction | Drug | Women |
| Phentolamine InjectionExamine how IV phentolamine impacts sympathetic transduction | Drug | Women |
Primary outcome
Sympathetic transduction
Time frame: 1 day (single study visit)
Assessing the relative change in blood flow (Doppler ultrasound) following an increase in sympathetic nerve activity.
2 secondary outcomes
Blood flow
Time frame: 1 day (single study visit)
Muscle sympathetic nerve activity
Time frame: 1 day (single study visit)
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 15 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propranolol Hydrochloride and Phentolamine Injection in people with Menopause, run by University of Missouri-Columbia at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jacqueline Limberg, PhD (573-882-2420, limbergj@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic transduction (time frame: 1 day (single study visit)). 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 15 Sep 2025.