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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT03995251
Eligibility Criteria:
Inclusion Criteria:
* Men with cirrhosis of any etiology
* Sarcopenia
* CTP 6-12
Exclusion Criteria:
* Hepatocellular carcinoma
* Other known malignancy,
* CTP \> 12
* Acute liver injury
* Prostate disease,
* Known hypersensitivity to testosterone therapy,
* Polycythaemia (haematocrit \>55%),
* Uncontrolled hypertension (\>160/90 mmHg despite treatment),
* Uncontrolled obstructive sleep apnoea,
* Severe renal dysfunction (estimated glomerular filtration rate \<30ml/min)
* Uncontrolled epilepsy, migraine, or significant cardiac insufficiency (New York Heart Association class III or IV or LVEF \< 45-50%.
* CKD (Chronic Kidney Disease) - eGFR (Glomerular Filtration Rate) \<60%
* Platelet count below 30,000 or taking warfarin
* Failure to give consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03995251
Study Brief:
Protocol Section:
NCT03995251