Role of Menopause in Thermoregulation

The Pennsylvania State University (PENNSTATE)

Status and phase: Enrolling; Phase 4

Conditions: Aging; Menopause

Treatments: Other: placebo patch; Drug: Estradiol patch; Other: cellulose placebo; Drug: Elagolix Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06798571

Study 25435

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 42 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Premenopausal estrogen suppression

Experimental group

Description:

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.

Treatment:

Other: cellulose placebo

Drug: Elagolix Oral Tablet

Postmenopausal estrogen supplementation

Experimental group

Description:

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.

Treatment:

Drug: Estradiol patch

Other: placebo patch