Clomiphene Citrate for Rotator Cuff Repair Healing
This study is looking at whether a medication called Clomiphene Citrate can help men heal better after surgery for a torn rotator cuff (shoulder tendon). Rotator cuff tears are common and can cause pain and weakness, and sometimes the tendon doesn't heal well after surgery. Researchers believe that low levels of sex hormones might play a role in this. In this study, men aged 40 to 80 who are having their first rotator cuff repair for a tear larger than 1 cm will be randomly assigned to take either Clomiphene Citrate or a placebo (an inactive pill) every other day. All participants will have the same surgery and recovery plan. The main goal is to see if Clomiphene Citrate improves tendon healing, which will be checked with an MRI scan about 6 months after surgery. This study aims to enroll 58 men.
- Study design
- This is a randomized study where 58 men will receive either Clomiphene Citrate or a placebo, along with standard rotator cuff repair surgery.
- What's involved
- Participants will undergo rotator cuff repair surgery and take a pill every other day. An MRI will be performed about 6 months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Tendon healing will be assessed at 6 months (±4 weeks) post-operatively.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial
At a glance
Conditions
NCT04944836
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Utah
Salt Lake City, Utahno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Magnetic Resonance Imaging (MRI) tendon healing Post-opTo 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.