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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06798571
- Acronym / sponsor ID
- Study 25435
- Keywords
- Thermoregulation, Heat Stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects participate in 6 experiments, 3 for each treatment (Elagolix OR Estradiol and placebo). The order of treatment is random.
| Arm | Type | Receives |
|---|---|---|
| Premenopausal estrogen suppression | Experimental | Drug: Elagolix Oral Tablet, Other: cellulose placeboParticipants 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. |
| Postmenopausal estrogen supplementation | Experimental | Drug: Estradiol patch, Other: placebo patchParticipants 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. |
Who may qualify
- Ages
- 42 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women ages 42-64
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elagolix Oral TabletAlso: Orilissa2 x 200 mg tablet | Drug | Premenopausal estrogen suppression |
| Estradiol patch0.05 mg/day patch | Drug | Postmenopausal estrogen supplementation |
| cellulose placeboplacebo tablet | Other | Premenopausal estrogen suppression |
| placebo patchplacebo patch | Other | Postmenopausal estrogen supplementation |
Primary outcome
Skin Blood Flow
Time frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
Skin blood flow response to whole body heating is continuously monitored
Local Sweat Rate
Time frame: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
A small sweat capsule is placed on the forearm for the duration of whole body heating.
Core Temperature
Time frame: Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)
Changes in body temperature are measured through a telemetry pill swallowed before each experiment.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia K. Leach, MS contact
W. Larry Kenney, Ph.D. principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact W. Larry Kenney, Ph.D. (814-863-1672, w7k@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.