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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 already scheduled for major surgery requiring an overnight hospital stay
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
No Placebo-Only Group

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 scheduled for a major surgery that requires staying in the hospital overnight.
Select...
I am scheduled for a major surgery that requires staying in the hospital overnight.
Select...
I am willing to complete the study's assessments before and after surgery.

Timeline

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
9%
high hematocrit
4%
pyschiatric ilness
3%
arthroplasty
3%
osteoarthritis
3%
laceration
2%
excision of bone spur
2%
stroke
2%
coronary stent
2%
myocardial infarction
2%
diverticulitis
1%
irritability
1%
infection of an appendectomy wound
1%
knee replacement surgery
1%
atypical chest pain
1%
cellulitis
1%
knee replacement
1%
abscess
1%
appendicitis
1%
GI tract perforation
1%
knee arthroscopy
1%
new-onset atrial fibrillation
1%
Congestive heart failure
1%
infected appendectomy wound
1%
infected spider bite
1%
shingles
1%
hemochromatosis
1%
upper respiratory infection
1%
dyspnea
1%
lung carcinoma
1%
priapism
1%
mastitis
1%
alopecia
1%
acne
1%
depression
1%
headache
1%
ingrown toenail
1%
heel pain
1%
vertebral fracture
1%
sleep apnea
1%
retinal injury
1%
prostate enlargement
1%
mood swings
1%
foot pain
1%
heartburn
1%
back pain
1%
gallstones
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1: Testosterone Cypionate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,586 Previous Clinical Trials
41,242,126 Total Patients Enrolled
Emory UniversityLead Sponsor
1,622 Previous Clinical Trials
2,890,780 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.

Media Library

Testosterone Cypionate Clinical Trial Eligibility Overview. Trial Name: NCT04731376 — Phase 1
Low Testosterone Research Study Groups: Arm I (testosterone cypionate), Arm II (best practice)
Low Testosterone Clinical Trial 2023: Testosterone Cypionate Highlights & Side Effects. Trial Name: NCT04731376 — Phase 1
Testosterone Cypionate 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731376 — Phase 1

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Florida
New York
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Emory University Hospital/Winship Cancer Institute
~18 spots leftby Oct 2024