[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551121":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":69,"centralContacts":73,"locations":81,"responsibleParty":100,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":12,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":84,"whyStopped":12,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,13,19,26,31,36],{"label":9,"type":10,"description":11,"interventionNames":12},"CONTROL (men + women)","NO_INTERVENTION","The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"STRESS (men + women): Multi-Stressor Training","ACTIVE_COMPARATOR","Research volunteers will be randomized into the stress exposure group (STRESS) will undergo a 4-week exercise training program consisting of 5 consecutive days of strenuous physical training followed by 2 days of recovery (energy balance, no structured exercise). The exercise training program will consist of military-relevant physical training exercises (e.g., load carriage, aerobic and resistance exercises) that progressively increase in duration and intensity to increase exercise energy expenditure. Participants will perform multiple exercises per day using a variety of endurance and muscle loading modalities designed to mimic movements typically observed during real-life military operations.",[18],"Other: Multi-Stressor Training",{"label":20,"type":21,"description":22,"interventionNames":23},"SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g","EXPERIMENTAL","In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, men will be administered 1.25g\u002Fday (SUPPRESS) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and\u002For stomach area daily.",[24,18,25],"Drug: Goserelin 3.6 MG","Drug: Testosterone gel (AndroGel 1.25g)",{"label":27,"type":21,"description":28,"interventionNames":29},"SUPPRESS (women): Multi-stressor training + Zoladex + Placebo patch","In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, women in the SUPRESS group will receive a placebo transdermal patch.",[24,18,30],"Drug: Placebo Patch",{"label":32,"type":21,"description":33,"interventionNames":34},"REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g","Following GnRH agonist administration, men will be administered 5g\u002Fday (REPLACE) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and\u002For stomach area daily.",[24,18,35],"Drug: Testosterone gel (AndroGel 5g)",{"label":37,"type":21,"description":38,"interventionNames":39},"REPLACE (women): Multi-Stressor Training + Zoladex + Climara Pro Patch","Following GnRH agonist administration, women, the REPLACE group will receive a transdermal estradiol (0.045 mg\u002Fday) + levonorgestrel (0.015 mg\u002Fday) patch (Climara Pro, Bayer, NJ) to be placed on a clean, dry area of the skin on the lower",[24,18,40],"Drug: Estradiol \u002F Levonorgestrel Transdermal System [Climara Pro]",[42,49,53,57,61,65],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Goserelin 3.6 MG","Goserelin acetate (Zoladex) is a gonadotropin-releasing hormone agonist (GnRH). GnRH agonists induce a transient increase in sex hormone concentrations, but subsequently inhibit gonadotropin secretion and the production of testosterone in men and estrogen in women. An equilibration period will occur to allow steroid concentrations to reduce.",[32,37,20,27],[48],"Zoladex",{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":12},"Multi-Stressor Training","A 4-week physical training program that mimics military training.",[32,37,14,20,27],{"type":43,"name":54,"description":55,"armGroupLabels":56,"otherNames":12},"Testosterone gel (AndroGel 5g)","Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).",[32],{"type":43,"name":58,"description":59,"armGroupLabels":60,"otherNames":12},"Testosterone gel (AndroGel 1.25g)","Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).",[20],{"type":43,"name":62,"description":63,"armGroupLabels":64,"otherNames":12},"Estradiol \u002F Levonorgestrel Transdermal System [Climara Pro]","Female subjects will be randomly assigned to receive a estrogen\u002F progesterone patch.",[37],{"type":43,"name":66,"description":67,"armGroupLabels":68,"otherNames":12},"Placebo Patch","Female subjects will be randomly assigned to receive a placebo patch identical to the Climara Pro patch.",[27],[70],{"name":71,"affiliation":5,"role":72},"Bradley C Nindl, PhD","PRINCIPAL_INVESTIGATOR",[74,78],{"name":71,"role":75,"phone":76,"phoneExt":12,"email":77},"CONTACT","412-246-0460","bnindl@pitt.edu",{"name":79,"role":75,"phone":76,"phoneExt":12,"email":80},"Kristin J Koltun, PhD","kjk116@pitt.edu",[82],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Neuromuscular Research Laboratory","RECRUITING","Pittsburgh","Pennsylvania","15203","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-79.99589,40.44062,{"lat":94,"lon":93},[97],{"name":98,"role":75,"phone":76,"phoneExt":12,"email":99},"Brian J Martin, PhD","bjm135@pitt.edu",{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Bradley Nindl","Professor",[105],{"name":106,"class":107},"U.S. Army Medical Research and Development Command","FED","100551121","phase-4-adaptions-and-resiliency-to-multi-stressor-operations-100551121",false,"NCT06455969","Adaptions and Resiliency to Multi-Stressor OpeRations","Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training","ARMOR","Inclusion Criteria:\n\n1. Age 18-40 years\n2. body mass index (BMI) 18-30 kg\u002Fm2\n3. weight stable (±10 lbs) in past 2 months\n4. takes part in moderate physical activity for at least 150 minutes\u002Fweek\n5. currently free of upper or lower body \u002Fextremity injury or impairment\n6. able to commit to study duration\n7. agrees to adhere to study requirements\n8. not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician\n9. in men, total testosterone concentration within normal physiological range (300-1000 ng\u002FdL)\n10. in women, eumenorrheic (cycles of 26-35 days) and not using hormonal contraceptives for previous 3 months\n\nExclusion Criteria:\n\n1. Current smoker\n2. current clinical diagnosis of an eating disorder\n3. use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes\n4. current oligo\u002Famenorrhea in women\n5. any metabolic or endocrine disease\n6. has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising\n7. currently pregnant or becomes pregnant during the study\n8. history of heart condition OR high blood pressure\n9. treating physician requires subject participates in medically supervised physical activity only\n10. history of drug addiction, or regular use of recreational drugs\n11. currently undergoing treatment for or have a history of mental health conditions\n12. irregular lab results (e.g., PSA \\>3 ng\u002FmL)\n13. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency\n14. Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates (oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit), calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU\u002Fday), anti-convulsants, depot medroxyprogesterone within 6 months.\n15. History of deep vein thrombosis, pulmonary embolism, or clotting disorders.\n16. History of stroke or myocardial infarction\n17. Serum 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n18. Thyroid dysfunction\n19. Serum creatinine \\> 2 mg\u002FdL\n20. Personal history or history of a first-degree relative with breast cancer\n21. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2x the upper limit of normal\n22. Serum bilirubin \\> 2 mg\u002FdL\n23. Serum alkaline phosphatase \\> 150 U\u002FL\n24. Plasma hemoglobin \\\u003C 10 gm\u002FdL\n25. Hematocrit \\> 50\n26. Fracture within the last 6 months.\n27. Serum testosterone level \\\u003C 270 or \\> 1070 ng\u002FdL\n28. Systolic blood pressure \\> 160 or diastolic blood pressure \\> 95\n29. Active substance abuse\n30. Triglycerides \\> 150 fasting\n31. History of hereditary angioedema\n32. History of chest pain at rest, during daily activities of living, or when performing physical activity\n33. Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years\n34. Recreational drug use more than 2 times per month in each of the previous 6 months\n35. Self-reported vision is worse than 20\u002F20.\n36. Personal history or history of a first-degree relative with breast cancer\n37. Experienced a fracture within the last 6 months\n38. participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration\n39. Diagnosed with eating disorder\n40. Have food allergies, intolerance, restriction, or special diet needs\n41. History of endometriosis\n42. Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement\n43. Have undiagnosed abnormal vaginal bleeding\n44. Currently breastfeeding or within 2 months after stopping breastfeeding\n45. Have dietary restrictions",true,"ALL","18 Years","40 Years",{"count":121,"type":122},120,"ESTIMATED","INTERVENTIONAL",[125],"PHASE4","Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.\n\nThe goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.",[128,129],"Musculoskeletal Injury","Hypogonadism",[131,132,133,134,135],"Military","Multi-stressor Training","Tendon","Muscle","Bone","2025-08-18",{"date":138,"type":139},"2025-08-24","ACTUAL",{"date":141,"type":139},"2024-07-15",{"date":143,"type":122},"2026-08-01",{"name":102,"class":6},1]