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

NCT05722301 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Harris Hip Score

  patient-reported outcome measure

  3 months

• Harris Hip Score

  patient-reported outcome measure

  1 year

• Forgotten Joint Score

  patient-reported outcome measure

  3 months

• Forgotten Joint Score

  patient-reported outcome measure

  1 year

Secondary Outcomes (4)

• Visual Analog Scale

  3 months

• Visual Analog Scale

  1 year

• Patient Satisfaction (reported from questionnaire)

  3 months

• Patient Satisfaction (reported from questionnaire)

  1 year

Study Arms (2)

Testosterone Therapy

EXPERIMENTAL

Drug: Testosterone Therapy

No Testosterone Therapy

PLACEBO COMPARATOR

Other: No Testosterone Therapy

Interventions

Testosterone Therapy 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).

Testosterone Therapy

No Testosterone Therapy OTHER

For the sham procedure no pellets will be implanted.

No Testosterone Therapy

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients
• 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.

Sponsors & Collaborators

• American Hip Institute: lead

Study Sites (1)

American Hip Institute Research Foundation

Des Plaines, Illinois, 60018, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: February 10, 2023
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)