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Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

NCT04456530 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-31

No results posted yet for this study

Summary

The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.

Conditions

  • Muscle Atrophy
  • Surgery
  • Knee Injuries and Disorders
  • Complication of Surgical Procedure
  • Trauma

Interventions

DRUG

Aveed 750 MG in 3 ML IM Injection

Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.

OTHER

Normal Saline 3 ML IM Injection

Participants in the Control Group will receive two IM normal saline injections 1 month apart.

Sponsors & Collaborators

  • The Stone Research Foundation for Sports Medicine and Arthritis

    lead OTHER

Principal Investigators

  • Mani Vessal, Ph.D. · Stone Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2021-12-30
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456530 on ClinicalTrials.gov