NCT05722301

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: American Hip Institute · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DRUG	Testosterone Therapy	The testosterone pellet implantation will be performed 2 weeks before surgery. The dose is determined by baseline levels of sex hormone binding globulin (SHBG) in the following manner: If SHBG \> 60nmol/L implant 5 Testosterone Compounded 200mg (total 1000mgs testosterone). If SHBG 41-59 nmol/L implant 4 Testosterone Compounded 200mg (total 800mgs testosterone). If SHBG \<40 nmol/L implant 3 Testosterone Compounded 200mg (total 600mgs testosterone).
OTHER	No Testosterone Therapy	For the sham procedure no pellets will be implanted.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2023-02-10
• Last updated: 2023-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study