Recruiting

Estrogen & Heat Stress

Sponsor:

Penn State University

Code:

NCT06798571

Conditions

Menopause

Aging

Eligibility Criteria

Sex: Female

Age: 42 - 64

Healthy Volunteers: Accepted

Interventions

Elagolix Oral Tablet

Estradiol patch

cellulose placebo

placebo patch

Study Details

Brief 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

Menopause

Aging

Study ID

NCT06798571

Start date

Mar 1, 2025

Status verified date

Jun, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 42 - 64

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Premenopausal estrogen suppression

Participants take a cellulose placebo tablet for 4 days prior to baseline testing and continue until experimental visits are complete. Following completion of placebo testing, participants begin taking 400 mg/day Elagolix for 4 days prior to testing and continue until experimental visits are complete.

experimental: Postmenopausal estrogen supplementation

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.

Interventions

Elagolix Oral Tablet

2 x 200 mg tablet

Estradiol patch

0.05 mg/day patch

cellulose placebo

placebo tablet

placebo patch

placebo patch

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

W. Larry Kenney, Ph.D.

814-863-1672w7k@psu.edu

Olivia K. Leach, MS

okl5046@psu.edu

Locations

Noll Laboratory

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

W. Larry Kenney, Ph.D.

814-863-1672w7k@psu.edu

Olivia Leach, MS

okl5046@psu.edu

More Information

Sponsor

Penn State University

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Thermoregulation
  • Heat Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-06-24.