Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40-80
SponsorUniversity of Utah

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 whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.

Eligibility criteria

Qualifiers

A plan for a primary rotator cuff repair

Male sex

>1 cm tear width, full thickness supraspinatus/infraspinatus tear

Disqualifiers

Active infection

Pre-operative testosterone supplementation

Known diagnosis of secondary testicular failure or testosterone deficiency

Medically unfit for operative intervention

Trial design

Treatments tested in this trial

  • Clomiphene Citrate
  • Rotator Cuff Repair

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators