NCT06798571

Role of Menopause in Thermoregulation

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Penn State University · Academic / Other
• Sex: Female
• Age: 42 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Menopause
• Aging

Interventions

Type	Name	Description
DRUG	Elagolix Oral Tablet	2 x 200 mg tablet
DRUG	Estradiol patch	0.05 mg/day patch
OTHER	cellulose placebo	placebo tablet
OTHER	placebo patch	placebo patch

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-01-29
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study