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NCT01595581 · ClinicalTrials.gov registry record · Phase 3

Testosterone Administration and ACL Reconstruction in Men

A Phase 3 study, sponsored by University of Southern California.

Completed
Registry status
Phase 3
Development phase
14
Enrollment target

NCT01595581: Completed Phase 3 study, sponsored by University of Southern California.

NCT01595581 is a Phase 3 study that has completed, run by University of Southern California. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01595581, a Phase 3 study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
Phase 3
Development phase
14 participants
Enrollment target

Study 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.

Primary Outcome

Relative changes in lean mass from 2 weeks prior to surgery to 6 weeks, 12 weeks, and 24 weeks following surgery between the two groups.

Interventions

  • DRUG Placebo
  • DRUG Testosterone

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-04
Est. Completion 2015-05
Phase Phase 3
University of Southern California

617 total trials

What the finished NCT01595581 record still lists

NCT01595581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01595581 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01595581 about?

NCT01595581 is a clinical study titled "Testosterone Administration and ACL Reconstruction in Men". 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 ...

What is the current status of trial NCT01595581?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2012-04. Estimated completion is 2015-05.

What interventions are being tested in trial NCT01595581?

The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG).

Who is sponsoring clinical trial NCT01595581?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01595581's enrollment target sits among peer trials

14 1983rd of 2000 higher than 17 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01595581, the US trial registry maintained by the National Library of Medicine. NCT01595581 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.