Clinical trial

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

Name

2100208

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2025-07-01

Trial end

2025-07-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Placebo

Participants will receive a placebo in pill form.

Arms:

Cold pressor test, Hypercapnia, Hypoxia

Propranolol

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

Arms:

Cold pressor test, Hypercapnia, Hypoxia

Gemtesa

Participants will receive oral gemtesa (75 mg).

Arms:

Cold pressor test, Hypercapnia, Hypoxia

Size

Primary endpoint

Forearm blood flow

Change from baseline to 5 minutes.

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

2 products

1 drug

4 indications

Organization

University of Missouri-Columbia

Drug

Varlilumab

Indication

Aging