What side effects are associated with this type of intervention?

Testosterone replacement therapy (TRT) for low testosterone can lead to several side effects. Cardiovascular risks include an increased likelihood of major adverse cardiovascular events such as myocardial infarction and stroke. Metabolic changes may involve alterations in cholesterol levels and an increased risk of developing conditions like diabetes. Other potential side effects include erythrocytosis (increased red blood cell count), which can elevate the risk of blood clots, and prostate-related issues such as benign prostatic hyperplasia or exacerbation of pre-existing prostate cancer. Additionally, TRT can cause skin reactions at the application site, mood swings, and sleep apnea.

What prior FDA approvals exist?

The FDA has approved several testosterone replacement therapies for the treatment of low testosterone, which have anabolic effects on muscle and bone tissue. These include testosterone gels (such as AndroGel and Testim), testosterone injections (such as Depo-Testosterone and Aveed), and testosterone patches (such as Androderm). These treatments aim to restore normal testosterone levels, thereby improving physical function, increasing lean body mass, and stimulating bone formation.

What other types of research exist?

Promising alternatives to Testosterone Replacement Therapy for low testosterone patients include anabolic-androgenic hormones for their muscle and bone anabolic effects, and bone-modifying agents like bisphosphonates (e.g., alendronate, risedronate) and denosumab for their bone health benefits.

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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

Must not have

Patient with history of prostate radiation/chemotherapy treatment and has experienced bounce or rise in PSA

Patient with history of prostatectomy with detectable prostate specific antigen (PSA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving testosterone to men with low levels can help them recover better from major urologic surgery by making them stronger and healthier. Testosterone therapy has been studied extensively and shown to improve various health outcomes in men with low testosterone levels, including muscle mass, bone density, libido, stamina, and cognition.

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.

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.

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

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

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

Exclusion Criteria

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

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I had prostate cancer treatment and my PSA levels have gone up since.

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I had prostate surgery and my PSA levels are detectable.

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I have heart failure that is not well-managed.

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I have a history of pituitary gland disorders.

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I am currently on hormone replacement therapy or have used testosterone in the past year.

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I have had surgery to remove one or both of my testicles.

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I have had a blood clot in the past year.

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

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

Primary study objectives

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 2024 Phase 2 trial • 36 Patients • NCT03516812

58%

Fatigue

50%

Nausea

36%

Pain

22%

Constipation

19%

Anemia

19%

Anorexia

17%

Vomiting

14%

Dysgeusia

11%

Creatinine increase

11%

Diarrhea

Nocturia

Dizziness or Lightheadedness

Weight loss

Cough

Insomnia

Edema

Hypercalcemia

Abdominal pain

Memory impairment

Thromboembolic event

Urinary retention

Stroke

Subdural hematoma

Myocardial infarction

Rib fracture

Cord compression

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Olaparib, Testosterone Enanthate or 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 2

~150

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Testosterone replacement therapy (TRT) works by directly supplementing testosterone levels in hypogonadal men through various delivery methods like injections, gels, patches, or oral formulations. The exogenous testosterone binds to androgen receptors in muscle and bone tissues, stimulating protein synthesis and muscle growth, and promoting bone formation, which increases bone density. This is important for patients with low testosterone as it helps alleviate symptoms such as muscle weakness, fatigue, and increased fracture risk, thereby enhancing their overall quality of life.

Androgen replacement therapy in the aging male.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,928 Previous Clinical Trials

41,017,938 Total Patients Enrolled

Emory UniversityLead Sponsor

1,700 Previous Clinical Trials

2,604,498 Total Patients Enrolled

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

Emory University

6 Previous Clinical Trials

732 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.