drugset / Trial / NCT05722301

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

NCT05722301

Phase 3 Withdrawn American Hip Institute
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-11-01
Primary completion
2020-11-01
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Small molecule 600 mg Other
Subject Testosterone Small molecule 800 mg Other
Subject Testosterone Small molecule 1000 mg Other

Indications