Health TrialsbyHealthPanel

Role of Menopause in Thermoregulation

ConditionsMenopauseAging
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age42-64
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women ages 42-64

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Elagolix Oral Tablet

    Drug

    2 x 200 mg tablet

  • Estradiol patch

    Drug

    0.05 mg/day patch

  • cellulose placebo

    Other intervention

    placebo tablet

  • placebo patch

    Other intervention

    placebo patch

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Premenopausal estrogen suppressionExperimental treatment 2 interventions
Group B: Postmenopausal estrogen supplementationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Skin Blood Flow

Skin blood flow response to whole body heating is continuously monitored

Time frame
Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
2

Local Sweat Rate

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

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

Core Temperature

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

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

Secondary outcomes

1

Body Mass

Body mass is measured on a scale.

Time frame
Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
2

Skin Temperature

Mean skin temperature is calculated from a weighted average of skin temperature from 4 different sites.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

Source ClinicalTrials.gov
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