Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
24 participants
INTERVENTIONAL
2025-03-01
2026-07-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
Elagolix Oral Tablet
2 x 200 mg tablet
cellulose placebo
placebo tablet
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.
Estradiol patch
0.05 mg/day patch
placebo patch
placebo patch
Interventions
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Elagolix Oral Tablet
2 x 200 mg tablet
Estradiol patch
0.05 mg/day patch
cellulose placebo
placebo tablet
placebo patch
placebo patch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
42 Years
64 Years
FEMALE
Yes
Sponsors
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Penn State University
OTHER
Responsible Party
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W. Larry Kenney
Professor
Principal Investigators
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W. Larry Kenney, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
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Noll Laboratory
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Study 25435
Identifier Type: -
Identifier Source: org_study_id
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