CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14 enrolled
Drug / intervention
Testosterone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01595581
NCT01595581Phase 3Completed
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The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery

University of Southern California·interventional·Posted May 10, 2012·Updated Mar 2, 2022

In Brief

A Phase 3 clinical trial evaluating Testosterone and Placebo for Muscle Atrophy and 3 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscle Atrophy, ACL Reconstruction, Trauma, Osteoarthritis
CountriesUnited States
CollaboratorsBoston University, University of Oregon

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2012
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.1 years ago

Interventions

Testosteronedrug

8 weeks of testosterone administration beginning 2 weeks before ACL surgery

Placebodrug

8 weeks of saline administration beginning 2 weeks before ACL surgery