Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial

March 17, 2026 updated by: Peter Chalmers, University of Utah
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 So when the treatment is withdrawn testosterone levels can go very low until feedback mechanisms in the body motivate it to make more.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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Peterr Chalmerrs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. A plan for a primary rotator cuff repair
  2. Male sex
  3. >1 cm tear width, full thickness supraspinatus/infraspinatus tear

Exclusion Criteria

  1. Active infection
  2. Pre-operative testosterone supplementation
  3. Known diagnosis of secondary testicular failure or testosterone deficiency
  4. Medically unfit for operative intervention
  5. Revision surgery
  6. Unwillingness to participate in the study, including post-operative imaging
  7. Inability to read or comprehend written instructions
  8. Prisoner
  9. Concomitant patch augmentation or tendon-transfer
  10. Untreated prostate cancer
  11. Liver disease
  12. Pituitary or hypothalamic dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
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.
Procedure: Rotator Cuff Repair
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.
Experimental: Clomiphene
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.
Procedure: Rotator Cuff Repair
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.
Drug: Clomiphene Citrate
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
To be collected at 6 months (±4 weeks) post-operatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons (ASES) Score Pre-op
Time Frame: To be collected within six months pre-operatively.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
To be collected at 6 months (±4 weeks) post-operatively.
Strength Assessment Pre-op
Time Frame: To be collected within six months pre-operatively.
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.
To be collected within six months pre-operatively.
Strength Assessment 6 weeks
Time Frame: To be collected at six weeks (±2 weeks) post-operatively.
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.
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.
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.
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.
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.
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 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.
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 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.
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 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.
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.
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.
To be collected at 6 months (±4 weeks) post-operatively.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Hormone Measurement Surgery
Time Frame: To be collected at the time of surgery.
Blood will be drawn and the following serum laboratory values will be collected: testosterone, bio-available testosterone, estradiol, all of which are reported in ng/dL.
To be collected at the time of surgery.
Luteinizing Hormone Measurement Surgery
Time Frame: To be collected at the time of surgery.
Blood will be drawn and serum luteinizing hormone values will be collected. These are reported in IU/L.
To be collected at the time of surgery.
Serum Hormone Measurement 12 weeks
Time Frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Blood will be drawn and the following serum laboratory values will be collected: testosterone, bio-available testosterone, and estradiol, all of which are reported in ng/dL.
To be collected at 12 weeks (±2 weeks) post-operatively.
Luteinizing Hormone Measurement 12 weeks
Time Frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Blood will be drawn and serum luteinizing hormone values will be collected. These are reported in IU/L.
To be collected at 12 weeks (±2 weeks) post-operatively.
Pill Count Surgery
Time Frame: To be collected at the time of surgery.
Subjects will be asked how many pills they have taken to determine patient compliance. Deviations from protocol will be recorded.
To be collected at the time of surgery.
Pill Count 6 weeks
Time Frame: To be collected at six weeks (±2 weeks) post-operatively.
Subjects will be asked how many pills they have taken to determine patient compliance. Deviations from protocol will be recorded.
To be collected at six weeks (±2 weeks) post-operatively.
Pill Count 12 weeks
Time Frame: To be collected at 12 weeks (±2 weeks) post-operatively.
Subjects will be asked how many pills they have taken to determine patient compliance. Deviations from protocol will be recorded.
To be collected at 12 weeks (±2 weeks) post-operatively.
Pill Count 6 months
Time Frame: To be collected at 6 months (±4 weeks) post-operatively.
Subjects will be asked how many pills they have taken to determine patient compliance. Deviations from protocol will be recorded.
To be collected at 6 months (±4 weeks) post-operatively.
Averse Event Assessment Surgery
Time Frame: To be collected at the time of surgery.
At each visit patients will be queried regarding adverse events. Patients will asked about the following specific adverse events side effects: anxiety, decreased energy/fatigue, mood instability, difficulty sleeping, decreased libido, visual changes, bleeding, infection, complications from anesthesia, the need for further surgery. In addition, any post-operative injections will be recorded.
To be collected at the time of surgery.
Averse Event Assessment 6 weeks
Time Frame: To be collected at six weeks (±2 weeks) post-operatively.
At each visit patients will be queried regarding adverse events. Patients will asked about the following specific adverse events side effects: anxiety, decreased energy/fatigue, mood instability, difficulty sleeping, decreased libido, visual changes, bleeding, infection, complications from anesthesia, the need for further surgery. In addition, any post-operative injections will be recorded.
To be collected at six weeks (±2 weeks) post-operatively.
Averse Event Assessment 12 weeks
Time Frame: To be collected at 12 weeks (±2 weeks) post-operatively.
At each visit patients will be queried regarding adverse events. Patients will asked about the following specific adverse events side effects: anxiety, decreased energy/fatigue, mood instability, difficulty sleeping, decreased libido, visual changes, bleeding, infection, complications from anesthesia, the need for further surgery. In addition, any post-operative injections will be recorded.
To be collected at 12 weeks (±2 weeks) post-operatively.
Averse Event Assessment 6 months
Time Frame: To be collected at 6 months (±4 weeks) post-operatively.
At each visit patients will be queried regarding adverse events. Patients will asked about the following specific adverse events side effects: anxiety, decreased energy/fatigue, mood instability, difficulty sleeping, decreased libido, visual changes, bleeding, infection, complications from anesthesia, the need for further surgery. In addition, any post-operative injections will be recorded.
To be collected at 6 months (±4 weeks) post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCRHRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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