Role of Menopause in Thermoregulation

Last updated: April 10, 2025
Sponsor: Penn State University
Overall Status: Active - Recruiting

Phase

4

Condition

Aging

Menopause

Treatment

Estradiol patch

Elagolix Oral Tablet

placebo patch

Clinical Study ID

NCT06798571
Study 25435
  • Ages 42-64
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women ages 42-64

Exclusion

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

Study Design

Total Participants: 24
Treatment Group(s): 4
Primary Treatment: Estradiol patch
Phase: 4
Study Start date:
March 01, 2025
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Noll Laboratory

    University Park, Pennsylvania 16802
    United States

    Active - Recruiting

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