Hormone therapy to improve healing after shoulder surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effects of sex hormone therapy on healing after rotator cuff repair surgery in men with low hormone levels. Participants will be randomly assigned to receive either clomiphene citrate, which stimulates the body to produce testosterone and estrogen, or a placebo while recovering from surgery. The study aims to determine if increasing hormone levels can enhance tendon healing, reduce pain, and improve shoulder function. The research is based on the hypothesis that hormone deficiencies may contribute to both the occurrence of rotator cuff tears and the failure of surgical repairs.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Peter Chalmers
• Email: chalmerspractice@hsc.utah.edu
• Phone: 8015870063

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears

  This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.

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• Biomarkers to see if rotator cuff repairs will heal after surgery

  This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.

  Recruiting University of Iowa · Iowa City, Iowa · NCT07781553

• Mobilization with Movement for people with rotator cuff lesions

  This trial will test whether Mobilization with Movement helps reduce pain, improve shoulder function, and restore joint position sense in adults with rotator cuff lesions.

  Recruiting Kirsehir Ahi Evran Universitesi · Kırşehir · NCT07383038

• Does age-related muscle loss change rotator cuff tear patterns?

  We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.

  Recruiting Haydarpasa Numune Training and Research Hospital · Istanbul, Üsküdar · NCT07183774

• Impact of neck nerve compression (cervical radiculopathy) on recovery after rotator cuff repair

  This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.

  Recruiting Biruni University · Istanbul, Istanbul · NCT07001566

• Using virtual reality to help rehabilitate shoulder injuries

  This study tests whether using virtual reality can make shoulder rehabilitation more engaging and effective for people with shoulder injuries.

  Recruiting La Tour Hospital · Meyrin, Canton of Geneva · NCT06963983

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.