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Sex Hormone Supplementation for Rotator Cuff Repair

Phase 2

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A plan for a primary rotator cuff repair

Male sex

Must not have

Pre-operative testosterone supplementation

Untreated prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be collected at 6 months (±4 weeks) post-operatively.

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial studies if increasing sex hormones can improve shoulder pain and function after tendon repair surgery.

Who is the study for?

This trial is for men planning to undergo primary rotator cuff repair surgery, specifically those with a tear width greater than 1 cm and full-thickness tears in the supraspinatus or infraspinatus tendons. It's aimed at men who have low sex hormone levels.

What is being tested?

The study is testing if taking sex hormone therapy (Clomiphene Citrate) after shoulder tendon repair surgery can improve healing and reduce pain compared to a placebo. Participants will be randomly assigned to either receive the hormone therapy or a placebo.

What are the potential side effects?

Sex hormone therapy like Clomiphene Citrate may cause side effects such as mood swings, vision changes, dizziness, nausea, and could potentially affect testosterone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a primary repair of my rotator cuff.

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I am male.

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I have a tear larger than 1 cm in my shoulder's tendon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking testosterone before surgery.

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My prostate cancer has not been treated.

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I have been diagnosed with low testosterone or secondary testicular failure.

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My pituitary or hypothalamus is not functioning properly.

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I am scheduled for or have had a revision surgery.

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I am not healthy enough for surgery.

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I currently have an infection.

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I am having or have had a tendon repair with additional support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be collected at 6 months (±4 weeks) post-operatively.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be collected at 6 months (±4 weeks) post-operatively.

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be collected at 6 months (±4 weeks) post-operatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnetic Resonance Imaging (MRI) tendon healing Post-op

Secondary study objectives

American Shoulder and Elbow Surgeons (ASES) Score 12 weeks

American Shoulder and Elbow Surgeons (ASES) Score 6 months

American Shoulder and Elbow Surgeons (ASES) Score 6 weeks

+19 more

Other study objectives

Averse Event Assessment 12 weeks

Averse Event Assessment 6 months

Averse Event Assessment 6 weeks

+9 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ClomipheneExperimental Treatment2 Interventions

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.

Group II: ControlPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clomifene

FDA approved

0 / 11Eligibility criteria met