RecruitingPhase 4NCT06798571

Role of Menopause in Thermoregulation

The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women


Sponsor

Penn State University

Enrollment

24 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 42 YearsMax Age: 64 Years

Inclusion Criteria1

  • Women ages 42-64

Exclusion Criteria7

  • 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

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Interventions

DRUGElagolix Oral Tablet

2 x 200 mg tablet

DRUGEstradiol patch

0.05 mg/day patch

OTHERcellulose placebo

placebo tablet

OTHERplacebo patch

placebo patch


Locations(1)

Noll Laboratory

University Park, Pennsylvania, United States

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NCT06798571


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