Hormonal intervention to prevent injuries in military personnel during training
Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training
This study is testing whether hormone therapy can help military personnel train better and avoid injuries during tough training sessions.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06455969 on ClinicalTrials.gov |
What this trial studies
This study investigates how hormonal interventions can improve muscle, tendon, and bone function in military personnel undergoing multi-stressor training. It focuses on the effects of testosterone and estrogen replacement on physical and psychological performance, particularly in response to stress. By examining the suppression of the hypothalamic-pituitary-gonadal (HPG) axis during strenuous training, the study aims to determine if hormone replacement can mitigate injury risks and performance decrements. The research will provide evidence-based guidance for the safe use of hormone therapy in military settings.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy military personnel aged 18-40 who engage in regular physical activity and meet specific hormonal and health criteria.
Not a fit: Patients with current injuries, metabolic disorders, or those using incompatible medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of musculoskeletal injuries among military personnel, enhancing their readiness and performance.
How similar studies have performed: While there have been studies on hormonal interventions in athletic populations, this specific approach in military training is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- Neuromuscular Research Laboratory — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Bradley C Nindl, PhD — University of Pittsburgh
- Study coordinator: Bradley C Nindl, PhD
- Email: bnindl@pitt.edu
- Phone: 412-246-0460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.