Menopause and Body Temperature Regulation Study

This study is looking at how menopause and aging affect your body's ability to handle heat. Researchers want to understand the role of estrogen in how pre- and postmenopausal women respond to heat stress. Participants will receive either Elagolix Oral Tablet (a medication that temporarily lowers estrogen), an Estradiol patch (which increases estrogen), or placebo (inactive) tablets and patches. The study will measure your skin blood flow, sweat rate, and core body temperature during heating experiments to see how these interventions affect your body's response. Women aged 42 to 64 can participate, but you cannot join if you have certain health conditions like Crohn's disease, use tobacco, or are currently on hormone therapy or hormonal contraceptives. The study aims to enroll 24 participants.

Study design
This is an interventional study with 24 participants. It compares the effects of Elagolix Oral Tablet, Estradiol patch, and placebo on body temperature regulation.
What's involved
You will undergo a medical screening including a physical exam and blood tests. You will complete 6 experimental trials, each involving passive and active heating experiments over an average of 3 weeks per intervention.
Compensation
Not stated in the trial record.
Follow-up
Your skin blood flow, local sweat rate, and core temperature will be monitored continuously during 3-hour heating experiments, with measurements taken over approximately 3 weeks for each intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06798571

Role of Menopause in Thermoregulation

Recruiting
PHASE4Ages 42–64InterventionalBasic science
Penn State University
~24 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Elagolix Oral TabletEstradiol patchcellulose placeboplacebo patch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Skin Blood Flow
Measured over Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
+2 more outcomes measured
Menopause
Aging
1 sites across 1 states
Pennsylvania1
  • W. Larry Kenney, Ph.D. · PRINCIPAL_INVESTIGATOR · The Pennsylvania State University

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Eligibility criteria

Inclusion

Women ages 42-64

Exclusion

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
  • Skin Blood FlowMonitored 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

  • Local Sweat RateMonitored 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.

  • Core TemperatureMonitored 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.