Recruiting
Phase 2

Hormone Supplementation

Sponsor:

University of Utah

Code:

NCT04944836

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Clomiphene Citrate

Rotator Cuff Repair

Study Details

Brief summary:

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.

Conditions

Rotator Cuff Tears

Study ID

NCT04944836

Start date

Mar 9, 2023

Status verified date

Mar, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control

All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the control group, these will be placebo. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery.

experimental: Clomiphene

All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery.

Interventions

Clomiphene Citrate

All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. In the control group, these will be placebo. These will be taken every other day for seven months beginning four weeks prior to surgery and extending for six months after surgery. After enrollment patients will be randomized. Patient will be assigned to the 2 groups using a permuted block randomization scheme with blocks of size 2, 4, and 6. Prior to initiation of the study opaque sealed envelopes will be prepared and thoroughly shuffled and then used sequentially during the study. These randomization assignments will be available to the pharmacy in a web-based format or by cards in sealed envelopes. A nonparticipant in the study (the pharmacy at our institution) will administer this process.

Rotator Cuff Repair

The operative protocol will be standardized in all patients. Both the operative protocol and post-operative rehabilitation protocol will be per our standard of care, without alteration. An arthroscopic approach will be used. In all cases a double-row rotator cuff repair using triple-loaded anchor(s) on the medial row will be used. Post-operatively all patients will be placed in a sling for six weeks. Active range of motion exercises will begin at six weeks post-operatively and strengthening will be delayed until 12 weeks post-operatively. In all phases of care our peri-operative and post-operative protocol for study patients will be similar to our current clinical practice to ensure generalizability.

Primary outcome measure

  • Magnetic Resonance Imaging (MRI) tendon healing Post-op [ Time Frame: To be collected at 6 months (±4 weeks) post-operatively. ]

Central Contacts and Locations

Central contacts

Peter Chalmers

8015870063chalmerspractice@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

More Information

Sponsor

University of Utah

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-03-19.