[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06798571":3,"trial-entities:NCT06798571":119,"trial-summary:NCT06798571":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":52,"secondary_outcomes":64,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":88,"locations":90,"central_contacts":109,"overall_officials":113,"references":117,"see_also_links":118},"NCT06798571","Study 25435","Role of Menopause in Thermoregulation","The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women","RECRUITING","2026-09-01","2026-06","2026-06-24","2025-03-01","Penn State University","OTHER",true,"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.\n\nAging 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.","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.\n\nSubjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles.\n\nEach 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.",[19,20],"Menopause","Aging",[22,23],"Thermoregulation","Heat Stress","INTERVENTIONAL","BASIC_SCIENCE",[27],"PHASE4",{"count":29,"type":30},24,"ESTIMATED",[32,40,45,49],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Elagolix Oral Tablet","2 x 200 mg tablet",[37],"Premenopausal estrogen suppression",[39],"Orilissa",{"type":33,"name":41,"description":42,"armGroupLabels":43},"Estradiol patch","0.05 mg\u002Fday patch",[44],"Postmenopausal estrogen supplementation",{"type":14,"name":46,"description":47,"armGroupLabels":48},"cellulose placebo","placebo tablet",[37],{"type":14,"name":50,"description":50,"armGroupLabels":51},"placebo patch",[44],[53,57,60],{"measure":54,"description":55,"timeFrame":56},"Skin Blood Flow","Skin blood flow response to whole body heating is continuously monitored","Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)",{"measure":58,"description":59,"timeFrame":56},"Local Sweat Rate","A small sweat capsule is placed on the forearm for the duration of whole body heating.",{"measure":61,"description":62,"timeFrame":63},"Core Temperature","Changes in body temperature are measured through a telemetry pill swallowed before each experiment.","Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)",[65,69],{"measure":66,"description":67,"timeFrame":68},"Body Mass","Body mass is measured on a scale.","Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)",{"measure":70,"description":71,"timeFrame":72},"Skin Temperature","Mean skin temperature is calculated from a weighted average of skin temperature from 4 different sites.","Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)","FEMALE","42 Years","64 Years",{"inclusion":77,"exclusion":79,"raw_text":87},[78],"Women ages 42-64",[80,81,82,83,84,85,86],"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","Inclusion Criteria:\n\n* Women ages 42-64\n\nExclusion Criteria:\n\n* Chron's disease, diverticulitis, or similar gastrointestinal disease\n* Abnormal resting exercise electrocardiogram (ECG)\n* Tobacco use\n* High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor\n* Assessment\n* Using hormone therapy\n* Using hormonal contraceptives",[89],"ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":106},"Noll Laboratory","University Park","Pennsylvania","16802","United States",[98,103],{"name":99,"role":100,"phone":101,"email":102},"W. Larry Kenney, Ph.D.","CONTACT","814-863-1672","w7k@psu.edu",{"name":104,"role":100,"email":105},"Olivia Leach, MS","okl5046@psu.edu",{"lat":107,"lon":108},40.80201,-77.85639,[110,111],{"name":99,"role":100,"phone":101,"email":102},{"name":112,"role":100,"email":105},"Olivia K. Leach, MS",[114],{"name":99,"affiliation":115,"role":116},"The Pennsylvania State University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":120,"biomarkers":122},[121],"Menopause present",[],{"nct_id":4,"found":15,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study with 24 participants. It compares the effects of Elagolix Oral Tablet, Estradiol patch, and placebo on body temperature regulation.","completed","Menopause and Body Temperature Regulation Study","This study is looking at how menopause and aging affect your body's ability to handle heat. Researchers want to understand the role of estrogen in how pre- and postmenopausal women respond to heat stress. Participants will receive either Elagolix Oral Tablet (a medication that temporarily lowers estrogen), an Estradiol patch (which increases estrogen), or placebo (inactive) tablets and patches. The study will measure your skin blood flow, sweat rate, and core body temperature during heating experiments to see how these interventions affect your body's response. Women aged 42 to 64 can participate, but you cannot join if you have certain health conditions like Crohn's disease, use tobacco, or are currently on hormone therapy or hormonal contraceptives. The study aims to enroll 24 participants.","Your skin blood flow, local sweat rate, and core temperature will be monitored continuously during 3-hour heating experiments, with measurements taken over approximately 3 weeks for each intervention.",123,"You will undergo a medical screening including a physical exam and blood tests. You will complete 6 experimental trials, each involving passive and active heating experiments over an average of 3 weeks per intervention.","Not stated in the trial record.",[34,41],"v2"]