MenopausePhase 4NCT06798571
Role of Menopause in Thermoregulation
A Phase 4 study testing Elagolix Oral Tablet and Estradiol patch in people with Menopause and Aging, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 64 years, women onlyHealthy volunteers can take part
- What is being tested?
- Elagolix Oral Tablet and Estradiol patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ages 42-64
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olivia K. Leach, MS contact
United States1 site, 1 recruiting
- Recruiting
Noll Laboratory
University Park, Pennsylvania, 16802
W. Larry Kenney, Ph.D., 814-863-1672, w7k@psu.edu
Olivia Leach, MS, okl5046@psu.edu
About this study
Official title: The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women
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.
Read the 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.
- Being tested
- Elagolix Oral Tablet, Estradiol patch, cellulose placebo, placebo patch
- Keywords
- Thermoregulation, Heat Stress
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elagolix Oral TabletDrug
Also called Orilissa
2 x 200 mg tablet
Estradiol patchDrug
0.05 mg/day patch
cellulose placeboOther
placebo tablet
placebo patchOther
placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal estrogen suppression | Experimental | 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. Receives: Drug: Elagolix Oral Tablet; Other: cellulose placebo |
| Postmenopausal estrogen supplementation | Experimental | 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. Receives: Drug: Estradiol patch; Other: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Blood Flow
Skin blood flow response to whole body heating is continuously monitored
Measured: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
Local Sweat Rate
A small sweat capsule is placed on the forearm for the duration of whole body heating.
Measured: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
Core Temperature
Changes in body temperature are measured through a telemetry pill swallowed before each experiment.
Measured: Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)
Secondary outcomes (2)
Body Mass
Body mass is measured on a scale.
Measured: Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
Skin Temperature
Mean skin temperature is calculated from a weighted average of skin temperature from 4 different sites.
Measured: Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects participate in 6 experiments, 3 for each treatment (Elagolix OR Estradiol and placebo). The order of treatment is random.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Larry Kenney, Penn State University
- Investigators
- W. Larry Kenney, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798571
- Sponsor's protocol ID
- Study 25435
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No