Impact of Early Aging and Menopause on the Vascular Respo... | NCT06417177

Studies
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

NCT06417177

Sponsor

University of Missouri-Columbia

Status

Recruiting

Last Update Posted

Sep 9, 2025Actual

Enrollment

75Estimated

Phase

Early Phase 1

Conditions

Aging
Menopause
Hypoxia
Vasodilation

Interventions

Placebo
Propranolol
Gemtesa

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2024Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

May 13, 2024

First Submission Date that Met QC Criteria

May 13, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2025

Last Update Posted Date

Sep 9, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jacqueline K Limberg, PhD, Associate Professor, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypoxia	Experimental	Participants will be exposed to hypoxia (low oxygen air) using a mask.	Drug: Placebo Drug: Propranolol Drug: Gemtesa
Cold pressor test	Experimental	Participants will be exposed to the cold pressor test (ice water on the foot).	Drug: Placebo Drug: Propranolol Drug: Gemtesa
Hypercapnia	Experimental	Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask.	Drug: Placebo Drug: Propranolol Drug: Gemtesa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Participants will receive a placebo in pill form.	Cold pressor test Hypercapnia Hypoxia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forearm blood flow	Blood flow in the forearm measured with venous occlusion plethysmography.	Change from baseline to 5 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female assigned at birth
Pre, peri- or post-menopausal
Healthy weight (BMI ≥18 and ≤30 kg/m2)

Exclusion Criteria:

Male (assigned at birth)
Pregnancy, breastfeeding
Use of hormone replacement therapies
Hysterectomy
Body mass index >30 kg/m2
Diagnosed sleep apnea
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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jacqueline Limberg	Contact	573-882-2544		limberglab@missouri.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri-Columbia	Recruiting	Columbia	Missouri	65211	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia
D000783	Aneurysm

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011433	Propranolol

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided