Rotator Cuff TearsPhase 2NCT04944836
Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
A Phase 2 study testing Clomiphene Citrate and Rotator Cuff Repair in people with Rotator Cuff Tears, run by University of Utah at 1 site in United States.
Trial summary
Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Clomiphene Citrate and Rotator Cuff Repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 1 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A plan for a primary rotator cuff repair
- Male sex
- >1 cm tear width, full thickness supraspinatus/infraspinatus tear
Who cannot join
- Active infection
- Pre-operative testosterone supplementation
- Known diagnosis of secondary testicular failure or testosterone deficiency
- Medically unfit for operative intervention
- Revision surgery
- Unwillingness to participate in the study, including post-operative imaging
Show all 12Show fewer
- Inability to read or comprehend written instructions
- Prisoner
- Concomitant patch augmentation or tendon-transfer
- Untreated prostate cancer
- Liver disease
- Pituitary or hypothalamic dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Peterr Chalmerrs
About this study
Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.
Read the detailed description
The rotator cuff is a system of tendons in the shoulder that stabilize the ball within the socket. These tendons frequently tear with age, which causes pain, weakness, and dysfunction in the shoulder. While these tears can be surgically repaired, they do not always heal. Our data suggest that deficiency of testosterone and estrogen can contribute to both tearing of the rotator cuff and failure of healing after rotator cuff repair. Testosterone can be converted into estrogen in the body through the aromatase enzyme, which is in both tendons and bones, as well as other tissues. Both testosterone and estrogen can improve bone quality. While testosterone is frequently prescribed for testosterone deficiency, when it is given your body no longer has the drive to make testosterone. So when the treatment is withdrawn testosterone levels can go very low until feedback mechanisms in the body motivate it to make more. As a result, testosterone is not usually given temporarily. For temporary treatment clomiphene avoids this issue. Clomiphene works at the feedback mechanisms within the body to trick the body into thinking testosterone and estrogen levels are low and thus to motivate it to make more testosterone and estrogen. However, clomiphene can only be given continuously to men, because women's estrogen levels regularly cycle up and down on a monthly basis and clomiphene interferes with this cycle. The purpose of this study is to determine whether clomiphene treatment decreases pain and improves function, increases tendon healing, and improves bone quality with rotator cuff repair in men. We hypothesize that clomiphene treatment will decrease pain and improve function, improve tendon healing, and improve bone quality with rotator cuff repair in men. This is a placebo-controlled study, so a control group of patients will received placebo pills, i.e. "sugar pills", instead of clomiphene. This is a randomized study, so patients enrolled in the study will be randomly assigned to the clomiphene group or the placebo group. This is a blinded study, so both the patients enrolled in the will not know whether they are in the clomiphene or the control group. This is a double-blinded study, so the doctors performing the surgeries and the study will not know whether each specific patient is in the clomiphene or the control group. Study participants will first start the clomiphene treatment one month before surgery and will continue the treatment for six months after surgery. Both before surgery and six months after surgery, study participants will fill out study questionnaires about shoulder pain and function. Both before surgery and six months after surgery, study participants will undergo an magnetic resonance imaging study to examine the rotator cuff tendons as well as the bone quality within the shoulder. The magnetic resonance imaging study after surgery is provided free to study participants. Study participants will be compensated for completing the study. These results are important because may lead to a better understanding of the problem, more effective treatment, and improved clinical outcomes for future patients.
- Conditions
- Rotator Cuff Tears
- Being tested
- Clomiphene Citrate, Rotator Cuff Repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene CitrateDrug
All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. In the control group, these will be placebo. These will be taken every other day for seven months beginning four weeks prior to surgery and extending for six months after surgery. After enrollment patients will be randomized. Patient will be assigned to the 2 groups using a permuted block randomization scheme with blocks of size 2, 4, and 6. Prior to initiation of the study opaque sealed envelopes will be prepared and thoroughly shuffled and then used sequentially during the study. These randomization assignments will be available to the pharmacy in a web-based format or by cards in sealed envelopes. A nonparticipant in the study (the pharmacy at our institution) will administer this process.
Rotator Cuff RepairProcedure or surgery
The operative protocol will be standardized in all patients. Both the operative protocol and post-operative rehabilitation protocol will be per our standard of care, without alteration. An arthroscopic approach will be used. In all cases a double-row rotator cuff repair using triple-loaded anchor(s) on the medial row will be used. Post-operatively all patients will be placed in a sling for six weeks. Active range of motion exercises will begin at six weeks post-operatively and strengthening will be delayed until 12 weeks post-operatively. In all phases of care our peri-operative and post-operative protocol for study patients will be similar to our current clinical practice to ensure generalizability.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the control group, these will be placebo. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery. Receives: Procedure: Rotator Cuff Repair |
| Clomiphene | Experimental | All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery. Receives: Drug: Clomiphene Citrate; Procedure: Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI) tendon healing Post-op
MRI scans will be assessed by observers blinded to the patient's allocation. For each patient, the post-operative MRI will be categorized as either "healed" or "non-healed". On post-operative MRI only those patients without tendon defects will be considered to be healed. This will be the primary outcome of the study. The investigators have previously demonstrated this measurement to be reliable.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Secondary outcomes (22)
American Shoulder and Elbow Surgeons (ASES) Score Pre-op
The ASES score is a patient survey that creates a score on a 100 point scale incorporating questions regarding shoulder pain and shoulder function. This survey contains 11 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected within six months pre-operatively.
American Shoulder and Elbow Surgeons (ASES) Score 6 weeks
The ASES score is a patient survey that creates a score on a 100 point scale incorporating questions regarding shoulder pain and shoulder function. This survey contains 11 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected at six weeks (±2 weeks) post-operatively.
American Shoulder and Elbow Surgeons (ASES) Score 12 weeks
The ASES score is a patient survey that creates a score on a 100 point scale incorporating questions regarding shoulder pain and shoulder function. This survey contains 11 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected at 12 weeks (±2 weeks) post-operatively.
American Shoulder and Elbow Surgeons (ASES) Score 6 months
The ASES score is a patient survey that creates a score on a 100 point scale incorporating questions regarding shoulder pain and shoulder function. This survey contains 11 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Simple Shoulder Test (SST) Score Pre-op
The SST score is a patient survey that creates a score on a 12 point scale incorporating questions regarding shoulder function. This survey contains 12 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected within six months pre-operatively.
Simple Shoulder Test (SST) Score 6 weeks
The SST score is a patient survey that creates a score on a 12 point scale incorporating questions regarding shoulder function. This survey contains 12 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected at six weeks (±2 weeks) post-operatively.
Simple Shoulder Test (SST) Score 12 weeks
The SST score is a patient survey that creates a score on a 12 point scale incorporating questions regarding shoulder function. This survey contains 12 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected at 12 weeks (±2 weeks) post-operatively.
Simple Shoulder Test (SST) Score 6 months
The SST score is a patient survey that creates a score on a 12 point scale incorporating questions regarding shoulder function. This survey contains 12 questions and takes ~3 minutes to complete. Higher scores indicate a better outcome.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Visual Analogue Score (VAS) for pain Pre-op
The VAS pain score is a patient survey that creates a score on a 10 point scale incorporating a single question regarding shoulder pain. This survey takes <1 minute to complete. Lower scores indicate a better outcome.
Measured: To be collected within six months pre-operatively.
Visual Analogue Score (VAS) for pain 6 weeks
The VAS pain score is a patient survey that creates a score on a 10 point scale incorporating a single question regarding shoulder pain. This survey takes <1 minute to complete. Lower scores indicate a better outcome.
Measured: To be collected at six weeks (±2 weeks) post-operatively.
Visual Analogue Score (VAS) for pain 12 weeks
The VAS pain score is a patient survey that creates a score on a 10 point scale incorporating a single question regarding shoulder pain. This survey takes <1 minute to complete. Lower scores indicate a better outcome.
Measured: To be collected at 12 weeks (±2 weeks) post-operatively.
Visual Analogue Score (VAS) for pain 6 months
The VAS pain score is a patient survey that creates a score on a 10 point scale incorporating a single question regarding shoulder pain. This survey takes <1 minute to complete. Lower scores indicate a better outcome.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Magnetic Resonance Imaging (MRI) proximal humeral bone quality Pre-op
Both the pre-operative and post-operative MRI scans will include a ultra-short time-echo (UTE) coronal sequence. On the UTE sequence, maximum humeral cortical thickness will be measured orthogonal to the axis of the shaft five, ten, and fifteen cm distal to the top the head, as we have previously demonstrated this measurement to be accurate and reliable.
Measured: To be collected within six months pre-operatively.
Magnetic Resonance Imaging (MRI) proximal humeral bone quality Post-op
Both the pre-operative and post-operative MRI scans will include a ultra-short time-echo (UTE) coronal sequence. On the UTE sequence, maximum humeral cortical thickness will be measured orthogonal to the axis of the shaft five, ten, and fifteen cm distal to the top the head, as we have previously demonstrated this measurement to be accurate and reliable.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Strength Assessment Pre-op
Rotator cuff strength, as measured with a handheld dynamometer, will be measured. Abduction strength will be measured at 30 degrees of flexion, 30 degrees of abduction, neutral rotation, and full elbow extension. External rotation strength will be measured with the arm in adduction, neutral rotation, and 90 degrees of elbow flexion. These measures will be performed by a single research coordinator.
Measured: To be collected within six months pre-operatively.
Strength Assessment 6 weeks
Rotator cuff strength, as measured with a handheld dynamometer, will be measured. Abduction strength will be measured at 30 degrees of flexion, 30 degrees of abduction, neutral rotation, and full elbow extension. External rotation strength will be measured with the arm in adduction, neutral rotation, and 90 degrees of elbow flexion. These measures will be performed by a single research coordinator.
Measured: To be collected at six weeks (±2 weeks) post-operatively.
Strength Assessment 12 weeks
Rotator cuff strength, as measured with a handheld dynamometer, will be measured. Abduction strength will be measured at 30 degrees of flexion, 30 degrees of abduction, neutral rotation, and full elbow extension. External rotation strength will be measured with the arm in adduction, neutral rotation, and 90 degrees of elbow flexion. These measures will be performed by a single research coordinator.
Measured: To be collected at 12 weeks (±2 weeks) post-operatively.
Strength Assessment 6 months
Rotator cuff strength, as measured with a handheld dynamometer, will be measured. Abduction strength will be measured at 30 degrees of flexion, 30 degrees of abduction, neutral rotation, and full elbow extension. External rotation strength will be measured with the arm in adduction, neutral rotation, and 90 degrees of elbow flexion. These measures will be performed by a single research coordinator.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Range of motion Pre-op
Range of motion will be recorded. Research personnel experienced with the use of video will measure active abduction, active forward elevation, active internal rotation in adduction , and active external rotation in adduction. These will be measured sequentially during a single continuous video, first with the video viewing from anteriorly while the subject abducts while standing against a wall, then while viewing from laterally while the subject elevates while standing adjacent to a wall, then while viewing from posteriorly while the subject internally rotates in adduction, and then while viewing from superiorly while the subject externally rotates while sitting in a chair. This protocol has been previously used in many publications. These videos will be saved using subject numbers and then evaluated using a digital protractor by a third-party observer.
Measured: To be collected within six months pre-operatively.
Range of motion 6 weeks
Range of motion will be recorded. Research personnel experienced with the use of video will measure active abduction, active forward elevation, active internal rotation in adduction , and active external rotation in adduction. These will be measured sequentially during a single continuous video, first with the video viewing from anteriorly while the subject abducts while standing against a wall, then while viewing from laterally while the subject elevates while standing adjacent to a wall, then while viewing from posteriorly while the subject internally rotates in adduction, and then while viewing from superiorly while the subject externally rotates while sitting in a chair. This protocol has been previously used in many publications. These videos will be saved using subject numbers and then evaluated using a digital protractor by a third-party observer.
Measured: To be collected at six weeks (±2 weeks) post-operatively.
Range of motion 12 weeks
Range of motion will be recorded. Research personnel experienced with the use of video will measure active abduction, active forward elevation, active internal rotation in adduction , and active external rotation in adduction. These will be measured sequentially during a single continuous video, first with the video viewing from anteriorly while the subject abducts while standing against a wall, then while viewing from laterally while the subject elevates while standing adjacent to a wall, then while viewing from posteriorly while the subject internally rotates in adduction, and then while viewing from superiorly while the subject externally rotates while sitting in a chair. This protocol has been previously used in many publications. These videos will be saved using subject numbers and then evaluated using a digital protractor by a third-party observer.
Measured: To be collected at 12 weeks (±2 weeks) post-operatively.
Range of motion 6 months
Range of motion will be recorded. Research personnel experienced with the use of video will measure active abduction, active forward elevation, active internal rotation in adduction , and active external rotation in adduction. These will be measured sequentially during a single continuous video, first with the video viewing from anteriorly while the subject abducts while standing against a wall, then while viewing from laterally while the subject elevates while standing adjacent to a wall, then while viewing from posteriorly while the subject internally rotates in adduction, and then while viewing from superiorly while the subject externally rotates while sitting in a chair. This protocol has been previously used in many publications. These videos will be saved using subject numbers and then evaluated using a digital protractor by a third-party observer.
Measured: To be collected at 6 months (±4 weeks) post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start9 Mar 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Chalmers, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944836
- Sponsor's protocol ID
- RCRHRT
- Status last verified
- Mar 2026
- First submitted
- 8 Jun 2021
- Last updated
- 19 Mar 2026
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
- ClinicalTrials.gov ID
- NCT04944836
- Acronym / sponsor ID
- RCRHRT
- Conditions
- Rotator Cuff Tears
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 30 Jun 2021 (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.
Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.
Detailed description
The rotator cuff is a system of tendons in the shoulder that stabilize the ball within the socket. These tendons frequently tear with age, which causes pain, weakness, and dysfunction in the shoulder. While these tears can be surgically repaired, they do not always heal. Our data suggest that deficiency of testosterone and estrogen can contribute to both tearing of the rotator cuff and failure of healing after rotator cuff repair. Testosterone can be converted into estrogen in the body through the aromatase enzyme, which is in both tendons and bones, as well as other tissues. Both testosterone and estrogen can improve bone quality. While testosterone is frequently prescribed for testosterone deficiency, when it is given your body no longer has the drive to make testosterone. So when the treatment is withdrawn testosterone levels can go very low until feedback mechanisms in the body motivate it to make more. As a result, testosterone is not usually given temporarily. For temporary treatment clomiphene avoids this issue. Clomiphene works at the feedback mechanisms within the body to trick the body into thinking testosterone and estrogen levels are low and thus to motivate it to make more testosterone and estrogen. However, clomiphene can only be given continuously to men, because women's estrogen levels regularly cycle up and down on a monthly basis and clomiphene interferes with this cycle. The purpose of this study is to determine whether clomiphene treatment decreases pain and improves function, increases tendon healing, and improves bone quality with rotator cuff repair in men. We hypothesize that clomiphene treatment will decrease pain and improve function, improve tendon healing, and improve bone quality with rotator cuff repair in men. This is a placebo-controlled study, so a control group of patients will received placebo pills, i.e. "sugar pills", instead of clomiphene. This is a randomized study, so patients enrolled in the study will be randomly assigned to the clomiphene group or the placebo group. This is a blinded study, so both the patients enrolled in the will not know whether they are in the clomiphene or the control group. This is a double-blinded study, so the doctors performing the surgeries and the study will not know whether each specific patient is in the clomiphene or the control group. Study participants will first start the clomiphene treatment one month before surgery and will continue the treatment for six months after surgery. Both before surgery and six months after surgery, study participants will fill out study questionnaires about shoulder pain and function. Both before surgery and six months after surgery, study participants will undergo an magnetic resonance imaging study to examine the rotator cuff tendons as well as the bone quality within the shoulder. The magnetic resonance imaging study after surgery is provided free to study participants. Study participants will be compensated for completing the study. These results are important because may lead to a better understanding of the problem, more effective treatment, and improved clinical outcomes for future patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Rotator Cuff RepairAll patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the control group, these will be placebo. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery. |
| Clomiphene | Experimental | Drug: Clomiphene Citrate, Procedure: Rotator Cuff RepairAll patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A plan for a primary rotator cuff repair
- Male sex
- >1 cm tear width, full thickness supraspinatus/infraspinatus tear
Key exclusion criteria (12 listed)
- Active infection
- Pre-operative testosterone supplementation
- Known diagnosis of secondary testicular failure or testosterone deficiency
- Medically unfit for operative intervention
- Revision surgery
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 |
|---|---|---|
| Clomiphene CitrateAll patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. In the control group, these will be placebo. These will be taken every other day for seven months beginning four weeks prior to surgery and extending for six months after surgery. After enrollment patients will be randomized. Patient will be assigned to the 2 groups using a permuted block randomization scheme with blocks of size 2, 4, and 6. Prior to initiation of the study opaque sealed envelopes will be prepared and thoroughly shuffled and then used sequentially during the study. These randomization assignments will be available to the pharmacy in a web-based format or by cards in sealed envelopes. A nonparticipant in the study (the pharmacy at our institution) will administer this process. | Drug | Clomiphene |
| Rotator Cuff RepairThe operative protocol will be standardized in all patients. Both the operative protocol and post-operative rehabilitation protocol will be per our standard of care, without alteration. An arthroscopic approach will be used. In all cases a double-row rotator cuff repair using triple-loaded anchor(s) on the medial row will be used. Post-operatively all patients will be placed in a sling for six weeks. Active range of motion exercises will begin at six weeks post-operatively and strengthening will be delayed until 12 weeks post-operatively. In all phases of care our peri-operative and post-operative protocol for study patients will be similar to our current clinical practice to ensure generalizability. | Procedure or surgery | Clomiphene, Control |
Primary outcome
Magnetic Resonance Imaging (MRI) tendon healing Post-op
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
MRI scans will be assessed by observers blinded to the patient's allocation. For each patient, the post-operative MRI will be categorized as either "healed" or "non-healed". On post-operative MRI only those patients without tendon defects will be considered to be healed. This will be the primary outcome of the study. The investigators have previously demonstrated this measurement to be reliable.
22 secondary outcomes
American Shoulder and Elbow Surgeons (ASES) Score Pre-op
Time frame: To be collected within six months pre-operatively.
American Shoulder and Elbow Surgeons (ASES) Score 6 weeks
Time frame: To be collected at six weeks (±2 weeks) post-operatively.
American Shoulder and Elbow Surgeons (ASES) Score 12 weeks
Time frame: To be collected at 12 weeks (±2 weeks) post-operatively.
American Shoulder and Elbow Surgeons (ASES) Score 6 months
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
Simple Shoulder Test (SST) Score Pre-op
Time frame: To be collected within six months pre-operatively.
Simple Shoulder Test (SST) Score 6 weeks
Time frame: To be collected at six weeks (±2 weeks) post-operatively.
Simple Shoulder Test (SST) Score 12 weeks
Time frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Simple Shoulder Test (SST) Score 6 months
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
Visual Analogue Score (VAS) for pain Pre-op
Time frame: To be collected within six months pre-operatively.
Visual Analogue Score (VAS) for pain 6 weeks
Time frame: To be collected at six weeks (±2 weeks) post-operatively.
Visual Analogue Score (VAS) for pain 12 weeks
Time frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Visual Analogue Score (VAS) for pain 6 months
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
Magnetic Resonance Imaging (MRI) proximal humeral bone quality Pre-op
Time frame: To be collected within six months pre-operatively.
Magnetic Resonance Imaging (MRI) proximal humeral bone quality Post-op
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
Strength Assessment Pre-op
Time frame: To be collected within six months pre-operatively.
Strength Assessment 6 weeks
Time frame: To be collected at six weeks (±2 weeks) post-operatively.
Strength Assessment 12 weeks
Time frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Strength Assessment 6 months
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
Range of motion Pre-op
Time frame: To be collected within six months pre-operatively.
Range of motion 6 weeks
Time frame: To be collected at six weeks (±2 weeks) post-operatively.
Range of motion 12 weeks
Time frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Range of motion 6 months
Time frame: To be collected at 6 months (±4 weeks) post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clomiphene Citrate and Rotator Cuff Repair in people with Rotator Cuff Tears, run by University of Utah 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 12 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Chalmers (8015870063, chalmerspractice@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) tendon healing Post-op (time frame: To be collected at 6 months (±4 weeks) post-operatively.). 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 19 Mar 2026.