Testosterone supplementation combined with exercise program to improve muscle condition in men affected by inclusion body myositis.

Not Applicable

Completed

• Conditions: Inclusion Body Myositis; Musculoskeletal - Other muscular and skeletal disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12618000755235
• Lead Sponsor: Perron Institute for Neurological and Translational Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-04
• Study Completion: 2020-09-30
• Last Update Posted: 16 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Adult men with a diagnosis of IBM in accordance with the ENMC criteria 2011 who are
able to provide informed consent.

Inclusion criterion for the extension study:
*Completion of the first 26 week phase of the study.

Exclusion Criteria

- Active cardiovascular disease (unstable angina, myocardial infarction, stroke, transient
ischaemic attack, or revascularisation procedure within the past 12 months)

- History of prostate cancer or other major medical comorbidity (e.g. advanced lung disease or cancer)

- Men on anti-androgen drugs for benign prostatic hyperplasia (BPH)

- Elevated blood pressure ( >160 mmHg systolic and > 100 mmHg diastolic)

- Abnormal prostate examinations suspicious for malignancy

- Total cholesterol > 6.5 mmol/L or LDL > 4.0 mmol/L

- eGFR <45 ml/min

- Testosterone concentration must be in the 5-14 nmol/L range with non-elevated haematocrit and PSA. Men with Testosterone concentration <5 nmol/L would be referred for endocrine assessment, and can participate if no pituitary or testicular disease is found.

Study & Design

• Study Type: Interventional
• Study Design: Not specified