Role of Menopause in Thermoregulation

Part of paid clinical trials in University Park, Pennsylvania.

Sponsor
Penn State University
Study ID
NCT06798571
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
42 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Elagolix Oral Tablet — DRUG
    2 x 200 mg tablet
  • Estradiol patch — DRUG
    0.05 mg/day patch
  • cellulose placebo — OTHER
    placebo tablet
  • placebo patch — OTHER
    placebo patch

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Skin Blood Flow [ Time Frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Noll LaboratoryUniversity ParkPennsylvania16802
W. Larry Kenney, Ph.D.
[email protected]
814-863-1672
Olivia Leach, MS
[email protected]

Find similar trials in University Park, PA

By condition
Menopause
By specialty
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By research site
Noll Laboratory· University Park, PA

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