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

• Status: Withdrawn
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: American Hip Institute
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Male patients

• 50 years of age and older

• Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.

Exclusion Criteria:

• 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.