Sympathetic Vascular Transduction Across the Menopause Tr... | NCT06787066

Studies
Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms

NCT06787066

Sponsor

University of Missouri-Columbia

Status

Recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

75Estimated

Phase

Early Phase 1

Conditions

Menopause

Interventions

Propranolol Hydrochloride
Phentolamine Injection

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

Jul 10, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jan 10, 2025

First Submission Date that Met QC Criteria

Jan 15, 2025

First Posted Date

Jan 22, 2025Actual

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 15, 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

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 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.

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
Women	Other	Women ages 18-70 years will participate.	Drug: Propranolol Hydrochloride Drug: Phentolamine Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propranolol Hydrochloride	Drug	Examine how IV propranolol impacts sympathetic transduction	Women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sympathetic transduction	Assessing the relative change in blood flow (Doppler ultrasound) following an increase in sympathetic nerve activity.	1 day (single study visit)

Secondary Outcomes

Measure	Description	Time Frame
Blood flow	Measuring femoral artery blood flow using Doppler ultrasound.	1 day (single study visit)
Muscle sympathetic nerve activity	Measuring the sympathetic nerve activity of the fibular nerve using a microelectrode .

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Assigned female at birth
18-70 years of age
Body mass index (BMI) <30 kg/m2

Exclusion Criteria:

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
Nerve/neurologic disease
Cardiovascular, hepatic, renal, respiratory disease
Blood pressure ≥140/90 mmHg
Diabetes, Polycystic ovarian syndrome
Communication barriers
Prescription medications

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, PhD	Contact	573-882-2420		limbergj@missouri.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri	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

Intervention Browse Module

MeSH Terms

ID	Term
D011433	Propranolol
D010646	Phentolamine

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided