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Hormone Therapy

Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.

N/A
Waitlist Available
Research Sponsored by Institute of Liver and Biliary Sciences, India
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions

Summary

* Study Population- Patient with cirrhosis with any aetiology with sarcopenia visiting ILBS OPD/IPDs who are willing to visit ILBS gymnasium twice weekly for first month. * Study Design- A Prospective Randomized Controlled Trial * Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019 * Sample Size:As shown by Eva Roman et al - in cirhotics with sarcopenia exercise increases mean lean appendicular mass , by 0.38 kg (14 patients, p \< 0.03), and Sinclair et al has shown testosterone (22 patients, p \<0.05)) to increase mean Appendicular lean mass by +1.69 kg - for 10% increase in APLM * we need to enroll 40 patients in each arm, and considering a los to follow up approx.10% , will require minimum 44 patients in each arm * We will therefore enroll and randomize 100 patients with 50 in each arm. Intervention - Testosterone Supplementation - Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations. Monitoring and assessment - On every visit patient will be inquired or evaluated for side effects like local site pain or hematoma , hypertension, headache, allergic reactions, acne, nausea , mood swings, pedal edema , breast enlargement and others.

Eligible Conditions
  • Liver Cirrhosis
  • Non-invasive Indices to Predict Hepatic Fibrosis in BA Patients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard Medical Treatment +Intramuscular Testosterone + ExercExperimental Treatment3 Interventions
Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations
Group II: Standard Medical Treatment+ExerciseActive Control2 Interventions
Standard Medical Treatment +Exercise
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Medical Treatment
2022
Completed Phase 4
~640

Find a Location

Who is running the clinical trial?

Institute of Liver and Biliary Sciences, IndiaLead Sponsor
255 Previous Clinical Trials
32,367 Total Patients Enrolled
87 Trials studying Liver Cirrhosis
14,116 Patients Enrolled for Liver Cirrhosis
~16 spots leftby Jan 2026