Status:

RECRUITING

Adaptions and Resiliency to Multi-Stressor OpeRations

Lead Sponsor:

Bradley Nindl

Collaborating Sponsors:

U.S. Army Medical Research and Development Command

Conditions:

Musculoskeletal Injury

Hypogonadism

Eligibility:

All Genders

18-40 years

Phase:

PHASE4

Brief Summary

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 responsi...

Detailed Description

Suppression of the reproductive hypothalamic-pituitary-gonadal (HPG) axis is a common physiological response to strenuous military training and can be difficult to replicate in simulated environments....

Eligibility Criteria

Inclusion Criteria:

  1. Age 18-40 years
  2. body mass index (BMI) 18-30 kg/m2
  3. weight stable (±10 lbs) in past 2 months
  4. takes part in moderate physical activity for at least 150 minutes/week
  5. currently free of upper or lower body /extremity injury or impairment
  6. able to commit to study duration
  7. agrees to adhere to study requirements
  8. not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician
  9. in men, total testosterone concentration within normal physiological range (300-1000 ng/dL)
  10. in women, eumenorrheic (cycles of 26-35 days) and not using hormonal contraceptives for previous 3 months

Exclusion Criteria:

  1. Current smoker
  2. current clinical diagnosis of an eating disorder
  3. use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes
  4. current oligo/amenorrhea in women
  5. any metabolic or endocrine disease
  6. has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising
  7. currently pregnant or becomes pregnant during the study
  8. history of heart condition OR high blood pressure
  9. treating physician requires subject participates in medically supervised physical activity only
  10. history of drug addiction, or regular use of recreational drugs
  11. currently undergoing treatment for or have a history of mental health conditions
  12. irregular lab results (e.g., PSA >3 ng/mL)
  13. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency
  14. 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/day), anti-convulsants, depot medroxyprogesterone within 6 months.
  15. History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
  16. History of stroke or myocardial infarction
  17. Serum 25-hydroxyvitamin D < 20 ng/mL
  18. Thyroid dysfunction
  19. Serum creatinine > 2 mg/dL
  20. Personal history or history of a first-degree relative with breast cancer
  21. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2x the upper limit of normal
  22. Serum bilirubin > 2 mg/dL
  23. Serum alkaline phosphatase > 150 U/L
  24. Plasma hemoglobin < 10 gm/dL
  25. Hematocrit > 50
  26. Fracture within the last 6 months.
  27. Serum testosterone level < 270 or > 1070 ng/dL
  28. Systolic blood pressure > 160 or diastolic blood pressure > 95
  29. Active substance abuse
  30. Triglycerides > 150 fasting
  31. History of hereditary angioedema
  32. History of chest pain at rest, during daily activities of living, or when performing physical activity
  33. Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years
  34. Recreational drug use more than 2 times per month in each of the previous 6 months
  35. Self-reported vision is worse than 20/20.
  36. Personal history or history of a first-degree relative with breast cancer
  37. Experienced a fracture within the last 6 months
  38. participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
  39. Diagnosed with eating disorder
  40. Have food allergies, intolerance, restriction, or special diet needs
  41. History of endometriosis
  42. Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement
  43. Have undiagnosed abnormal vaginal bleeding
  44. Currently breastfeeding or within 2 months after stopping breastfeeding
  45. Have dietary restrictions

Key Trial Info

Start Date :

July 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06455969

Start Date

July 15 2024

End Date

August 1 2026

Last Update

August 24 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Neuromuscular Research Laboratory

Pittsburgh, Pennsylvania, United States, 15203