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Recruiting NCT06798571

Role of Menopause in Thermoregulation

Phase IV Interventional Menopause Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Elagolix Oral Tablet, Estradiol patch, cellulose placebo, placebo patch.
Who it may be relevant to
Registry conditions: Menopause, Aging. Basic parameters: 42 years — 64 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women

Overview

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.

Detailed 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.

Interventions

  • Drug Elagolix Oral Tablet
    2 x 200 mg tablet
  • Drug Estradiol patch
    0.05 mg/day patch
  • Other cellulose placebo
    placebo tablet
  • Other placebo patch
    placebo patch

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • Body Mass [Time frame: Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)]
  • Skin Temperature [Time frame: Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Noll Laboratory — University Park

Identifiers

NCT: NCT06798571 · Study 25435

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗