NCT06787066

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for early_phase_1

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

January 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

January 10, 2025

Last Update Submit

September 8, 2025

Conditions

Menopause

Keywords

MenopauseSympathetic nerve activitySympathetic transductionBlood flowWomen's healthBlood pressure

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Blood flow

    1 day (single study visit)

  • Muscle sympathetic nerve activity

    1 day (single study visit)

Study Arms (1)

Women

OTHER

Women ages 18-70 years will participate.

Drug: Propranolol HydrochlorideDrug: Phentolamine Injection

Interventions

Propranolol HydrochlorideDRUG

Examine how IV propranolol impacts sympathetic transduction

Women
Phentolamine InjectionDRUG

Examine how IV phentolamine impacts sympathetic transduction

Women

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Assigned female at birth
  • years of age
  • Body mass index (BMI) \<30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Interventions

PropranololPhentolamine

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jacqueline Limberg, PhD

CONTACT

573-882-2420limbergj@missouri.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 22, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)