Sex Hormone Therapy for Rotator Cuff Tears
Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
Recruiting
Phase 2
Interventional Study
Rotator Cuff Tears
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 – 80
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 58 (estimated)
- Sponsor
- University of Utah · Other
Who this trial is looking for
This trial is looking for men with shoulder tendon tears who will undergo surgery. Participants will receive either hormone therapy or placebo pills to see if it helps with healing and pain after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
- I am scheduled for rotator cuff repair surgery.
- I am male.
- I have a full thickness tear wider than 1 cm.
You may not be able to join if
- I have an active infection.
- I have been taking testosterone before the surgery.
- I have a known condition causing low testosterone levels.
- I am not healthy enough for surgery.
- I need revision surgery.
- I do not want to take part in the study.
- I cannot read or understand written instructions.
- I have untreated prostate cancer.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This 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 in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test…
Trial Locations
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Eligibility Criteria
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 …
Contacts