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

NCT04944836 | Recruiting Phase 2 FDA Drug

• 1 other identifier: RCRHRT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Magnetic Resonance Imaging (MRI) tendon healing Post-op

  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.

  To be collected at 6 months (±4 weeks) post-operatively.

Secondary Outcomes (22)

• American Shoulder and Elbow Surgeons (ASES) Score Pre-op

  To be collected within six months pre-operatively.

• American Shoulder and Elbow Surgeons (ASES) Score 6 weeks

  To be collected at six weeks (±2 weeks) post-operatively.

• American Shoulder and Elbow Surgeons (ASES) Score 12 weeks

  To be collected at 12 weeks (±2 weeks) post-operatively.

• American Shoulder and Elbow Surgeons (ASES) Score 6 months

  To be collected at 6 months (±4 weeks) post-operatively.

• Simple Shoulder Test (SST) Score Pre-op

  To be collected within six months pre-operatively.

Other Outcomes (12)

• Serum Hormone Measurement Surgery

  To be collected at the time of surgery.

• Luteinizing Hormone Measurement Surgery

  To be collected at the time of surgery.

• Serum Hormone Measurement 12 weeks

  To be collected at 12 weeks (±2 weeks) post-operatively.

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Procedure: Rotator Cuff Repair

Clomiphene

EXPERIMENTAL

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.

Drug: Clomiphene Citrate; Procedure: Rotator Cuff Repair

Interventions

Clomiphene Citrate DRUG

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.

Clomiphene

Rotator Cuff Repair PROCEDURE

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.

Clomiphene; Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A plan for a primary rotator cuff repair
• Male sex
• \>1 cm tear width, full thickness supraspinatus/infraspinatus tear

You may not qualify if:

• Active infection
• Pre-operative testosterone supplementation
• Known diagnosis of secondary testicular failure or testosterone deficiency
• 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
• Untreated prostate cancer
• Liver disease
• Pituitary or hypothalamic dysfunction

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Peter Chalmers

CONTACT

8015870063; chalmerspractice@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 30, 2021
• Study Start: March 9, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)