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NCT04944836 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Rotator Cuff Tears, sponsored by University of Utah.

Recruiting
Registry status
Phase 2
Development phase
58
Enrollment target
1
Study location

NCT04944836: Recruiting Phase 2 study of Rotator Cuff Tears, sponsored by University of Utah.

NCT04944836 is a Phase 2 study of Rotator Cuff Tears that is actively recruiting participants, run by University of Utah. The registered enrollment target is 58 participants, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04944836, a Phase 2 study of Rotator Cuff Tears, is actively recruiting participants, sponsored by University of Utah.

RECRUITING
Registry status
Phase 2
Development phase
58 participants
Enrollment target
1
Study location

Study 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. 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Clomiphene Citrate
  • PROCEDURE Rotator Cuff Repair

Study Locations (1)

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2023-03-09
Est. Completion 2029-01-01
Phase Phase 2
University of Utah

818 total trials

What NCT04944836 shows while recruiting

NCT04944836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 2 interventions - of which Clomiphene Citrate is the first listed.

NCT04944836 reports a single indexed study location in Utah.

Frequently Asked Questions

What is clinical trial NCT04944836 about?

NCT04944836 is a clinical study titled "Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial". 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 ...

What is the current status of trial NCT04944836?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2023-03-09. Estimated completion is 2029-01-01.

What conditions does trial NCT04944836 study?

This clinical trial studies the following conditions: Rotator Cuff Tears.

What interventions are being tested in trial NCT04944836?

The interventions under investigation include: Clomiphene Citrate (DRUG), Rotator Cuff Repair (PROCEDURE).

Who is sponsoring clinical trial NCT04944836?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04944836 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Rotator Cuff Tears

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04944836's enrollment target sits among peer trials

58 16th of 20 higher than 5 of 20 other Rotator Cuff Tears trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Rotator Cuff Tears trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04944836, the US trial registry maintained by the National Library of Medicine. NCT04944836 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.