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New treatment option for Rotator Cuff Tears
Official title Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
ClinicalTrials.gov ID: NCT04944836
What this study is testing
What is Clomiphene Citrate?
Clomiphene Citrate is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for rotator cuff tears.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80, men only
You may be able to join if
- A plan for a primary rotator cuff repair
- Male sex
- \>1 cm tear width, full thickness supraspinatus/infraspinatus tear
You likely can't join if
- 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
See the full eligibility criteria
- A plan for a primary rotator cuff repair
- Male sex
- \>1 cm tear width, full thickness supraspinatus/infraspinatus tear
- 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
- Inability to read or comprehend written instructions
- Prisoner
- Concomitant patch augmentation or tendon-transfer
- Untreated prostate cancer
- Liver disease
- Pituitary or hypothalamic dysfunction
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.