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

NCT ID: NCT05722301

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-11-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Testosterone Therapy

Group Type: EXPERIMENTAL

Testosterone Therapy

Intervention Type: DRUG

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).

No Testosterone Therapy

Group Type: PLACEBO_COMPARATOR

No Testosterone Therapy

Intervention Type: OTHER

For the sham procedure no pellets will be implanted.

Interventions

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).

Intervention Type: DRUG

No Testosterone Therapy

For the sham procedure no pellets will be implanted.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Hip Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

American Hip Institute Research Foundation

Des Plaines, Illinois, United States

Countries

United States

Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id