Estradiol Supplementation and Rotator Cuff Repair
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Syndrome, Menopause Related Conditions, Menopause
In brief
Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.
Key facts
- Study ID
- NCT06318403
- Run by
- University of Utah
- People needed
- 58
- Starts
- 2028-03-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-03-19
Who can join
Age: 50 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- A plan for a primary rotator cuff repair
- Female sex (assigned sex at birth)
- >1 cm tear width, full thickness supraspinatus/infraspinatus tear
- Post-menopausal, as defined by at least twelve months since last menses
- Age 50-80
You may not qualify if…
- Active infection
- Baseline serum estradiol >20 pg/mL
- Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3
- Pre-operative systemic estradiol supplementation
- 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
- Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia
- Liver disease as documented in the medical record
- Active venous thromboembolic disease, such as deep venous thrombosis, pulmonary embolism, a history of these conditions, or a known predisposition to these disorders (such as Protein C, protein S, or antithrombin deficiency)
- Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders
- Isolated subscapularis tears
- Known anaphylactic reaction or hypersensitivity to estradiol, adhesive, or transdermal patches
Full record on ClinicalTrials.gov
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