Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06455969
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06455969
Study Brief:
Protocol Section:
NCT06455969