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Testosterone Replacement Therapy for Low Testosterone

Phase 1

Recruiting

Led By Kenneth Ogan, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Patients must be willing to do study's preoperative and post-operative assessment tools

Patients already scheduled for major surgery requiring an overnight hospital stay

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months

Awards & highlights

Study Summary

This trial is testing whether testosterone replacement therapy is safe around the time of major surgery. It may improve quality of life and decrease complications and length of hospital stay.

Who is the study for?

This trial is for adults with low testosterone who are scheduled for major urologic surgery requiring an overnight stay. They must be able to consent and willing to complete preoperative and post-operative assessments. Excluded are those with a history of prostate cancer treatment, current hormone therapy, steroid use, certain blood conditions, uncontrolled heart failure, or thromboembolic events within the last year.Check my eligibility

What is being tested?

The study tests if testosterone replacement therapy can improve recovery after major urologic surgery in patients with low testosterone. It aims to see if this treatment leads to shorter hospital stays and fewer complications by increasing muscle mass and physical function while reducing fat.See study design

What are the potential side effects?

Potential side effects may include changes in mood or libido, increased red blood cell count which can thicken blood, skin reactions at the injection site, fluctuating cholesterol levels, and possibly an increased risk of heart-related issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am willing to complete the study's assessments before and after surgery.

Select...

I am scheduled for a major surgery that requires staying in the hospital overnight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in frailty phenotype before and after surgery

Changes in quality of life before and after surgery

Discharge disposition

+7 more

Side effects data

From 2017 Phase 1 trial • 105 Patients • NCT01378299

high hematocrit

pyschiatric ilness

arthroplasty

osteoarthritis

laceration

excision of bone spur

stroke

coronary stent

myocardial infarction

diverticulitis

irritability

infection of an appendectomy wound

knee replacement surgery

atypical chest pain

cellulitis

knee replacement

abscess

appendicitis

GI tract perforation

knee arthroscopy

new-onset atrial fibrillation

Congestive heart failure

infected appendectomy wound

infected spider bite

shingles

hemochromatosis

upper respiratory infection

dyspnea

lung carcinoma

priapism

mastitis

alopecia

acne

depression

headache

ingrown toenail

heel pain

vertebral fracture

sleep apnea

retinal injury

prostate enlargement

mood swings

foot pain

heartburn

back pain

gallstones

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1: Testosterone Cypionate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (testosterone cypionate)Experimental Treatment3 Interventions

Patients with low testosterone levels receive testosterone cypionate IM QW for 3 months.

Group II: Arm II (best practice)Active Control3 Interventions

Patients with normal testosterone levels receive standard peri-operative care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality-of-Life Assessment

2017

Completed Phase 3

~4950

Testosterone Cypionate

2011

Completed Phase 1

~110

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,754 Total Patients Enrolled

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,596 Total Patients Enrolled

Kenneth Ogan, MD3.519 ReviewsPrincipal Investigator - Emory University Hospital/Winship Cancer Institute

Emory University

6 Previous Clinical Trials

532 Total Patients Enrolled

5Patient Review

They were extremely comprehensive and took care to ensure I understood what was happening every step of the way. They were also very passionate about providing high-quality care.