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NCT06798571PHASE4RecruitingAccepts Healthy Volunteers

Role of Menopause in Thermoregulation

Penn State University

Start Date

3/1/2025

Completion Date

9/1/2026

Summary

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

Detailed Description

Premenopausal and postmenopausal women will be recruited and different interventions will be given to each group. To mimic a postmenopausal hormone profile, premenopausal women will be given a GnRH antagonist, which acutely reduces estrogen concentrations. This induces a temporary post-menopausal state without compounding aging effects. Postmenopausal women will be given a transdermal estradiol patch to acutely raise estrogen concentrations. Supplementing estrogen in postmenopausal women allows for the effect of menopausal low estrogen concentration to be removed from the physiological effects of aging. Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles. Each subject will complete 6 (3 for each treatment) experimental trials. For each intervention, participants will complete one passive heating experiment first, followed by two active heating experiments.

Eligibility Criteria

Age Range: 42 years to 64 years

Inclusion Criteria: * Women ages 42-64 Exclusion Criteria: * Chron's disease, diverticulitis, or similar gastrointestinal disease * Abnormal resting exercise electrocardiogram (ECG) * Tobacco use * High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor * Assessment * Using hormone therapy * Using hormonal contraceptives

Interventions

DRUG

Elagolix Oral Tablet

DRUG

Estradiol patch

OTHER

cellulose placebo

OTHER

placebo patch

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Conditions

MenopauseAging

Locations

Noll Laboratory

University Park, Pennsylvania 16802

United States