AgingEarly Phase 1NCT06417177
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
A Early Phase 1 study testing Propranolol and Gemtesa in people with Aging and Menopause, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- What is being tested?
- Propranolol and Gemtesa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 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
- Female assigned at birth
- Pre, peri- or post-menopausal
- Healthy weight (BMI ≥18 and ≤30 kg/m2)
Who cannot join
- Male (assigned at birth)
- Pregnancy, breastfeeding
- Use of hormone replacement therapies
- Hysterectomy
- Body mass index >30 kg/m2
- Diagnosed sleep apnea
Show all 14Show fewer
- Current smoking/Nicotine/Drug use
- Nerve/neurologic disease
- Cardiovascular, hepatic, renal, respiratory disease
- Blood pressure ≥140/90 mmHg
- Diabetes, Polycystic ovarian syndrome
- Communication barriers
- Prescription medications
- Malignant cancer
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
The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.
- Conditions
- Aging, Menopause, Hypoxia, Vasodilation
- Being tested
- Placebo, Propranolol, Gemtesa
- Medical subject headings
- Hypoxia, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive a placebo in pill form.
PropranololDrug
Participants will receive oral propranolol (1 mg/kg).
GemtesaDrug
Participants will receive oral gemtesa (75 mg).
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Experimental | Participants will be exposed to hypoxia (low oxygen air) using a mask. Receives: Drug: Placebo; Drug: Propranolol; Drug: Gemtesa |
| Cold pressor test | Experimental | Participants will be exposed to the cold pressor test (ice water on the foot). Receives: Drug: Placebo; Drug: Propranolol; Drug: Gemtesa |
| Hypercapnia | Experimental | Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask. Receives: Drug: Placebo; Drug: Propranolol; Drug: Gemtesa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow
Blood flow in the forearm measured with venous occlusion plethysmography.
Measured: Change from baseline to 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start3 Jun 2024
- 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 AgingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT06417177
- Sponsor's protocol ID
- 2100208
- Status last verified
- Sep 2025
- First submitted
- 13 May 2024
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
- ClinicalTrials.gov ID
- NCT06417177
- Acronym / sponsor ID
- 2100208
- Conditions
- Aging, Menopause, Hypoxia, Vasodilation
- 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
- 3 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 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.
The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Experimental | Drug: Placebo, Drug: Propranolol, Drug: GemtesaParticipants will be exposed to hypoxia (low oxygen air) using a mask. |
| Cold pressor test | Experimental | Drug: Placebo, Drug: Propranolol, Drug: GemtesaParticipants will be exposed to the cold pressor test (ice water on the foot). |
| Hypercapnia | Experimental | Drug: Placebo, Drug: Propranolol, Drug: GemtesaParticipants will be exposed to hypercapnia (high carbon dioxide air) using a mask. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female assigned at birth
- Pre, peri- or post-menopausal
- Healthy weight (BMI ≥18 and ≤30 kg/m2)
Key exclusion criteria (14 listed)
- Male (assigned at birth)
- Pregnancy, breastfeeding
- Use of hormone replacement therapies
- Hysterectomy
- Body mass index >30 kg/m2
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 |
|---|---|---|
| PlaceboParticipants will receive a placebo in pill form. | Drug | Cold pressor test, Hypercapnia, Hypoxia |
| PropranololParticipants will receive oral propranolol (1 mg/kg). | Drug | Cold pressor test, Hypercapnia, Hypoxia |
| GemtesaParticipants will receive oral gemtesa (75 mg). | Drug | Cold pressor test, Hypercapnia, Hypoxia |
Primary outcome
Forearm blood flow
Time frame: Change from baseline to 5 minutes.
Blood flow in the forearm measured with venous occlusion plethysmography.
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 10 Sep 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.
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 and Gemtesa in people with Aging and 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 14 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 10 Sep 2026. 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 (573-882-2544, limberglab@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm blood flow (time frame: Change from baseline to 5 minutes.). 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 10 Sep 2026.