Arthroplasty, Replacement, HipPhase 3NCT05722301
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
A Phase 3 study testing Testosterone Therapy and No Testosterone Therapy in people with Arthroplasty, Replacement, Hip, run by American Hip Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Testosterone Therapy and No Testosterone Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 1 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients
- 50 years of age and older
- Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.
Who cannot join
- 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
Show all 9Show fewer
- Liver disease (as viewed by liver function tests)
- Testosterone free level greater than 10pg/mL
- Hematocrit >51%; PSA >= 3ng/mL.
Trial locations and contacts
1 site in 1 country.
United States1 site
American Hip Institute Research Foundation
Des Plaines, Illinois, 60018
About this study
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
- Being tested
- Testosterone Therapy, No Testosterone Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone TherapyDrug
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 TherapyOther
For the sham procedure no pellets will be implanted.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Therapy | Experimental | Not described Receives: Drug: Testosterone Therapy |
| No Testosterone Therapy | Placebo comparator | Not described Receives: Other: No Testosterone Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
patient-reported outcome measure
Measured: 3 months
Harris Hip Score
patient-reported outcome measure
Measured: 1 year
Forgotten Joint Score
patient-reported outcome measure
Measured: 3 months
Forgotten Joint Score
patient-reported outcome measure
Measured: 1 year
Secondary outcomes (4)
Visual Analog Scale
patient-reported outcome measure
Measured: 3 months
Visual Analog Scale
patient-reported outcome measure
Measured: 1 year
Patient Satisfaction (reported from questionnaire)
patient-reported outcome measure
Measured: 3 months
Patient Satisfaction (reported from questionnaire)
patient-reported outcome measure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2021 (estimated)
Why it stopped: Study was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Hip Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722301
- Sponsor's protocol ID
- 2
- Status last verified
- Feb 2023
- First submitted
- 16 Aug 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT05722301
- Acronym / sponsor ID
- 2
- Conditions
- Arthroplasty, Replacement, Hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Hip InstituteUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone Therapy | Experimental | Drug: Testosterone Therapy |
| No Testosterone Therapy | Placebo comparator | Other: No Testosterone Therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients
- 50 years of age and older
- Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone TherapyThe 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). | Drug | Testosterone Therapy |
| No Testosterone TherapyFor the sham procedure no pellets will be implanted. | Other | No Testosterone Therapy |
Primary outcome
Harris Hip Score
Time frame: 3 months
patient-reported outcome measure
Harris Hip Score
Time frame: 1 year
patient-reported outcome measure
Forgotten Joint Score
Time frame: 3 months
patient-reported outcome measure
Forgotten Joint Score
Time frame: 1 year
patient-reported outcome measure
4 secondary outcomes
Visual Analog Scale
Time frame: 3 months
Visual Analog Scale
Time frame: 1 year
Patient Satisfaction (reported from questionnaire)
Time frame: 3 months
Patient Satisfaction (reported from questionnaire)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone Therapy and No Testosterone Therapy in people with Arthroplasty, Replacement, Hip, run by American Hip Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.