Role of Menopause in Thermoregulation

What Was Tested

This registered phase 4 trial tested Elagolix (non-peptide).

Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men.

It had two arms (groups): Premenopausal estrogen suppression (experimental) and Postmenopausal estrogen supplementation (experimental).

Participants wear a transdermal estradiol patch or placebo patch for 5 days prior to testing and continue until experimental visits are complete. After 48 hr washout, participants then wear the alternative treatment for 5 days prior to testing until experimental visits are complete.

The registry classes the interventions as drug and other.

More on the Plan

Premenopausal and postmenopausal women will be recruited and different interventions will be given to each group.

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.

Who Took Part

The registry lists 24 planned participants were the target.

It was open to women only aged from 42 years up to 64 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women ages 42-64.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: chron's disease, diverticulitis, or similar gastrointestinal disease; abnormal resting exercise electrocardiogram (ecg); tobacco use.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Elagolix (non-peptide) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Elagolix (non-peptide) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Elagolix (non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2025-03-01 with completion listed for 2026-12-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Skin Blood Flow (time frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)). Local Sweat Rate (time frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)). Core Temperature (time frame: Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)).

It also tracked 2 secondary outcomes, for example Body Mass and Skin Temperature.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Elagolix (non-peptide) in 24 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Elagolix (non-peptide) compound page, all human trials.