Role of Menopause in Thermoregulation

NCT06798571 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Study 25435
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Thermoregulation; Heat Stress

Outcome Measures

Primary Outcomes (3)

• Skin Blood Flow

  Skin blood flow response to whole body heating is continuously monitored

  Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)

• Local Sweat Rate

  A small sweat capsule is placed on the forearm for the duration of whole body heating.

  Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)

• Core Temperature

  Changes in body temperature are measured through a telemetry pill swallowed before each experiment.

  Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)

Secondary Outcomes (2)

• Body Mass

  Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)

• Skin Temperature

  Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)

Study Arms (2)

Premenopausal estrogen suppression

EXPERIMENTAL

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.

Drug: Elagolix Oral Tablet; Other: cellulose placebo

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.

Drug: Estradiol patch; Other: placebo patch

Interventions

Elagolix Oral Tablet DRUG

2 x 200 mg tablet

Also known as: Orilissa

Premenopausal estrogen suppression

Estradiol patch DRUG

0.05 mg/day patch

Postmenopausal estrogen supplementation

cellulose placebo OTHER

placebo tablet

Premenopausal estrogen suppression

placebo patch OTHER

placebo patch

Postmenopausal estrogen supplementation

Eligibility Criteria

• Age: 42 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women ages 42-64

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Noll Laboratory

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

elagolix; Ortho Evra

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• W. Larry Kenney, Ph.D.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

W. Larry Kenney, Ph.D.

CONTACT

814-863-1672; w7k@psu.edu

Olivia K. Leach, MS

CONTACT

okl5046@psu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (participant, investigator)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects participate in 6 experiments, 3 for each treatment (Elagolix OR Estradiol and placebo). The order of treatment is random.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)