WomenEarly Phase 1NCT06520982
Early Neurovascular Adaptations in Aging Women
A Early Phase 1 study testing Norepinephrine, Isoproterenol and Acetylcholine in people with Women and Sympathetic Nervous System, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Our goal is to enhance our understanding of early vascular adaptations in aging women with an emphasis on the sympathetic nervous system. 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
- Women, Sympathetic Nervous System, Aging
- What is being tested?
- Norepinephrine, Isoproterenol and Acetylcholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2024to 30 Jun 2028
- 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 (AFAB)
- 18-70 years of age
Who cannot join
- Assigned male at birth (AMAB)
- Pregnancy, breastfeeding
- Body mass index ≥30 kg/m2
- Taking medications known to affect metabolic, autonomic, and/or respiratory function
- Oral hormonal contraception in last 6 month
- History of hormone replacement therapy
Show all 12Show fewer
- History of hyster- or oophor-ectomy
- Current smoking/Nicotine use
- Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
- Chronic disease
- Blood pressure ≥140/90 mmHg
- Communication barriers
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
Columbia, Missouri, 65211
Jacqueline K Limberg, Ph.D., 573-882-2420, limbergj@missouri.edu
About this study
Our goal is to enhance our understanding of early vascular adaptations in aging women with an emphasis on the sympathetic nervous system.
- Conditions
- Women, Sympathetic Nervous System, Aging, Blood Flow
- Being tested
- Norepinephrine, Isoproterenol, Acetylcholine, Nitroprusside, Estrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Infused intra-arterially in a dose-response fashion
IsoproterenolDrug
Infused intra-arterially in a dose-response fashion
AcetylcholineDrug
Infused intra-arterially in a dose-response fashion
NitroprussideDrug
Infused intra-arterially in a dose-response fashion
EstrogenDrug
Infused intra-arterially
| Study group | Role | What they receive |
|---|---|---|
| Women | Other | Women will be 18-70 years of age Receives: Drug: Norepinephrine; Drug: Isoproterenol; Drug: Acetylcholine; Drug: Nitroprusside; Drug: Estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of forearm blood flow
Measured: Change from baseline during infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start20 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jacqueline K Limberg, PhD, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520982
- Sponsor's protocol ID
- 2109189
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2024
- Last updated
- 26 Nov 2025
- Results posted
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neurovascular Adaptations in Aging Women
- ClinicalTrials.gov ID
- NCT06520982
- Acronym / sponsor ID
- 2109189
- Conditions
- Women, Sympathetic Nervous System, Aging, Blood Flow
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Jul 2024 (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.
Our goal is to enhance our understanding of early vascular adaptations in aging women with an emphasis on the sympathetic nervous system.
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: Norepinephrine, Drug: Isoproterenol, Drug: Acetylcholine, Drug: Nitroprusside, Drug: EstrogenWomen will be 18-70 years of age |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Assigned female at birth (AFAB)
- 18-70 years of age
Key exclusion criteria (12 listed)
- Assigned male at birth (AMAB)
- Pregnancy, breastfeeding
- Body mass index ≥30 kg/m2
- Taking medications known to affect metabolic, autonomic, and/or respiratory function
- Oral hormonal contraception in last 6 month
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 |
|---|---|---|
| NorepinephrineInfused intra-arterially in a dose-response fashion | Drug | Women |
| IsoproterenolInfused intra-arterially in a dose-response fashion | Drug | Women |
| AcetylcholineInfused intra-arterially in a dose-response fashion | Drug | Women |
| NitroprussideInfused intra-arterially in a dose-response fashion | Drug | Women |
| EstrogenInfused intra-arterially | Drug | Women |
Primary outcome
Magnitude of forearm blood flow
Time frame: Change from baseline during infusion
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 26 Nov 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 Norepinephrine, Isoproterenol and Acetylcholine in people with Women and Sympathetic Nervous System, 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 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: looking for participants now, as of the sponsor's last update on 26 Nov 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 K Limberg (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?
Magnitude of forearm blood flow (time frame: Change from baseline during infusion). 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 26 Nov 2025.