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

NCT06417177 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2100208
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Menopause; Hypoxia; Vasodilation

Outcome Measures

Primary Outcomes (1)

• Forearm blood flow

  Blood flow in the forearm measured with venous occlusion plethysmography.

  Change from baseline to 5 minutes.

Study Arms (3)

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

Placebo DRUG

Participants will receive a placebo in pill form.

Cold pressor test; Hypercapnia; Hypoxia

Propranolol DRUG

Participants will receive oral propranolol (1 mg/kg).

Cold pressor test; Hypercapnia; Hypoxia

Gemtesa DRUG

Participants will receive oral gemtesa (75 mg).

Cold pressor test; Hypercapnia; Hypoxia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia; Aneurysm

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Jacqueline Limberg

CONTACT

573-882-2544; limberglab@missouri.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)