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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am male.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Magnetic Resonance Imaging (MRI) tendon healing Post-op

Secondary outcome measures

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 outcome measures

Averse Event Assessment 12 weeks

Averse Event Assessment 6 months

Averse Event Assessment 6 weeks

+9 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,103 Previous Clinical Trials

1,781,659 Total Patients Enrolled

1 Trials studying Rotator Cuff Tears

58 Patients Enrolled for Rotator Cuff Tears

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Clomiphene received the stamp of approval from the Federal Drug Administration?

"Although there is no evidence of Clomiphene's efficacy, prior data suggests that it can still provide a safe treatment option and thus earned a score of 2."

Answered by AI

How many participants are being recruited for this research?

"Indeed, the data posted on clinicaltrials.gov confirms that this medical trial is actively recruiting participants as of November 8th 2023. The study was first published on March 9th 2023 and requires 58 individuals from only 1 site."

Answered by AI

Are there any unoccupied slots for participants in the trial?

"According to the details found on clinicaltrials.gov, this study is actively recruiting patients and has been listed since March 9th 2023 with its latest edit being made in November 8th 2023."

Answered by AI

Who are the ideal participants for this clinical research?

"58 candidates fitting the criteria of having a rotator cuff tear and being between 40 to 80 years old will be accepted into this medical trial."

Answered by AI

Does this trial allow for the participation of geriatric patients?

"The age range for this clinical trial is 40-80; if a patient falls outside of these bounds, there are 8 trials available to those under 18 and 109 open to patients over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Peter Chalmers 2023. "Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04944836.