Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT03995251
Status:
UNKNOWN
Last Update Posted:
2019-08-21
First Post:
2019-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis.
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men With Cirrhosis a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: