Role of Menopause in Thermoregulation

What this trial studies

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.

Conditions in scope

• Menopause
• Aging

Interventions

• Elagolix Oral Tablet (Drug) — 2 x 200 mg tablet
• Estradiol patch (Drug) — 0.05 mg/day patch
• cellulose placebo (Other) — placebo tablet
• placebo patch (Other) — placebo patch

Who can join

Women only · Ages 42 Years to 64 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2025-03-01
• Primary completion: 2026-06-01
• Last update posted: 2026-04-06
• First posted: 2025-01-29

Sponsor & contact

Lead sponsor: Penn State University (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Skin Blood Flow (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
• Local Sweat Rate (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.
• Core Temperature (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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.