Role of Menopause in Thermoregulation

NCT06798571 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Penn State University

    lead OTHER

Principal Investigators

  • W. Larry Kenney, Ph.D. · The Pennsylvania State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
42 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-06-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798571 on ClinicalTrials.gov