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Recruiting Phase 4 NCT06798571

NCT06798571 Role of Menopause in Thermoregulation

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Clinical Trial Summary
NCT ID NCT06798571
Status Recruiting
Phase Phase 4
Sponsor Penn State University
Condition Menopause
Study Type INTERVENTIONAL
Enrollment 24 participants
Start Date 2025-03-01
Primary Completion 2026-06-01

Eligibility & Interventions

Sex Female only
Min Age 42 Years
Max Age 64 Years
Study Type INTERVENTIONAL
All Conditions
Interventions
Elagolix Oral TabletEstradiol patchcellulose placebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 24 participants in total. It began in 2025-03-01 with a primary completion date of 2026-06-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

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

Contact & Investigator

Central Contact

W. Larry Kenney, Ph.D.

✉ w7k@psu.edu

📞 814-863-1672

Principal Investigator

W. Larry Kenney, Ph.D.

PRINCIPAL INVESTIGATOR

The Pennsylvania State University

Frequently Asked Questions

Who can join the NCT06798571 clinical trial?

This trial is open to female participants only, aged 42 Years or older, up to 64 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06798571 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT06798571 currently recruiting?

Yes, NCT06798571 is actively recruiting participants. Contact the research team at w7k@psu.edu for enrollment information.

Where is the NCT06798571 trial being conducted?

This trial is being conducted at University Park, United States.

Who is sponsoring the NCT06798571 clinical trial?

NCT06798571 is sponsored by Penn State University. The principal investigator is W. Larry Kenney, Ph.D. at The Pennsylvania State University. The trial plans to enroll 24 participants.

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