Testosterone Administration and ACL Reconstruction in Men

NCT01595581 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-03-02

Study results available
· View outcomes & findings →

Summary

This study is being done to test whether taking testosterone can prevent loss of muscle mass and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential for the development of male reproductive tissues and promotes increased muscle, bone mass, and the growth of body hair.

The investigators hope to learn whether testosterone given before and after ACL reconstructive surgery will increase muscle mass and strength and potentially improve recovery time following surgery.

Conditions

Interventions

DRUG

Testosterone

8 weeks of testosterone administration beginning 2 weeks before ACL surgery

DRUG

Placebo

8 weeks of saline administration beginning 2 weeks before ACL surgery

Sponsors & Collaborators

  • Boston University

    collaborator OTHER
  • University of Oregon

    collaborator OTHER
  • University of Southern California

    lead OTHER

Principal Investigators

  • Todd Schroeder, PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01595581 on ClinicalTrials.gov