Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Arthroplasty, Replacement, Hip

In brief

This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement. Subjects will be male patients \> 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease. All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo. A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects. Testosterone therapy will be administered once to each patient at 2 weeks before surgery. The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement, VAS for pain and satisfaction at regular intervals.

Key facts

Study ID

NCT05722301

Run by

American Hip Institute

People needed

0

Starts

2019-11-01

Expected to finish

2021-11-01

Last updated by the study team

2023-02-10

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male patients
• 50 years of age and older
• Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.

You may not qualify if…

• History of prostate cancer less than 5 years ago or those men whom are not considered to be cancer free
• History of breast cancer less than 5 years ago or those men whom are not considered to be cancer free
• History of deep vein thrombosis (DVT)
• Presence of Factor V Leiden (as seen in labs)
• Presence of Protein S Deficiency (as seen in labs)
• History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or stroke
• Liver disease (as viewed by liver function tests)
• Testosterone free level greater than 10pg/mL
• Hematocrit >51%; PSA >= 3ng/mL.

Where it is running

• American Hip Institute Research Foundation — Des Plaines, Illinois, United States

Full record on ClinicalTrials.gov

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