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NCT Number: NCT06798571

Role of Menopause in Thermoregulation

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.

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Key information

Conditions

Menopause Aging Heat Stress Disorders Wounds and Injuries

Age range

42 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elagolix Oral Tablet

Drug

2 x 200 mg tablet

Other names: Orilissa

Estradiol patch

Drug

0.05 mg/day patch

cellulose placebo

Other

placebo tablet

Placebo patch

Other

placebo patch

Primary outcomes

  1. Skin Blood Flow

    Time frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)

    Skin blood flow response to whole body heating is continuously monitored

  2. Local Sweat Rate

    Time frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)

    A small sweat capsule is placed on the forearm for the duration of whole body heating.

  3. Core Temperature

    Time frame: Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)

    Changes in body temperature are measured through a telemetry pill swallowed before each experiment.

Secondary outcomes

  1. Body Mass

    Time frame: Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)

    Body mass is measured on a scale.

  2. Skin Temperature

    Time frame: Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)

    Mean skin temperature is calculated from a weighted average of skin temperature from 4 different sites.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia K. Leach, MS

CONTACT

[email protected]

W. Larry Kenney, Ph.D.

CONTACT

[email protected]

814-863-1672

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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