Testosterone Replacement Therapy for Low Testosterone

Overseen By Kenneth Ogan, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Emory University

Must not be taking: Anabolic steroids

Disqualifiers: Prostatectomy, Orchiectomy, Pituitary disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether testosterone replacement therapy, specifically Testosterone Cypionate, can aid recovery after major urologic surgery in individuals with low testosterone. The researchers aim to determine if testosterone use results in shorter hospital stays and fewer complications. One group with low testosterone will receive the treatment, while another group with normal testosterone will receive standard care. The trial seeks participants scheduled for major surgery who can provide informed consent and complete assessments before and after surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical research.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently on hormone replacement therapy or have used testosterone in the last year, you would not be eligible to participate.

Is there any evidence suggesting that testosterone replacement therapy is likely to be safe for humans?

Research has shown that testosterone replacement therapy, such as testosterone cypionate, is generally safe for men with low testosterone levels. The FDA has approved it for treating low testosterone symptoms, indicating it has undergone some safety testing.

However, some side effects may occur, including fluid retention, which can cause swelling, and changes in urination frequency. Some studies have investigated potential heart-related risks, but results remain mixed, and more long-term safety data is still being gathered.

Overall, many individuals tolerate testosterone cypionate well, but discussing any concerns with a doctor is important, especially for those with a history of heart problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment options for low testosterone, which often include gels, patches, or oral medications, testosterone cypionate is administered as an intramuscular injection. This delivery method can offer a more controlled release of testosterone, potentially leading to more stable hormone levels over time. Researchers are excited because this could mean fewer fluctuations in testosterone levels, resulting in more consistent symptom relief and improved quality of life for patients. Additionally, the once-weekly injection schedule may offer greater convenience and adherence compared to daily treatments.

What evidence suggests that testosterone replacement therapy could be effective for low testosterone?

Studies have shown that testosterone replacement therapy can improve physical abilities and increase muscle mass in men with low testosterone levels. Research also suggests it may reduce body fat, leading to better overall body composition. In this trial, participants with low testosterone levels will receive testosterone cypionate to restore testosterone levels to normal. This treatment can enhance the quality of life for men with low testosterone. While testosterone therapy is used for hypogonadism, its effects on recovery from surgery, such as shorter hospital stays and fewer complications, remain under investigation. ^{1 2 3 6 7}

Who Is on the Research Team?

Kenneth Ogan, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Patients must be able to give informed consent

Exclusion Criteria

You take anabolic steroids.

Special populations: Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women and prisoners

You have had a single or undescended testicle in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with low testosterone levels receive testosterone cypionate intramuscularly once a week for 3 months

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including testosterone levels, hospital length of stay, and complications

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone Cypionate

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (testosterone cypionate) Experimental Treatment 3 Interventions

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

Group II: Arm II (best practice) Active Control 3 Interventions

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study evaluated different formulations for sustained-release testosterone patches, identifying Carbomer and CoTran™ 9712 as the most effective combination, achieving a drug release of 2.16 ± 0.36 mg, which could improve patient compliance compared to current therapies.

CoTran™ 9712 was found to be superior to CoTran™ 9702 in releasing testosterone, suggesting that optimizing the release membrane is crucial for developing effective extended-release testosterone therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Sustained Release Membranes Used in Formulating Low Strength Testosterone Reservoir Transdermal Patches. Vashishth, R., Chuong, MC., Duarte, JC., et al.[2023]

The study found that testosterone cypionate (deposteron) is genotoxic, as indicated by an increased number of micronuclei in the bone marrow of male Swiss mice after treatment with the highest dose.

Additionally, the highest dose of deposteron caused cytotoxic effects, evidenced by a decrease in the ratio of polychromatic to normochromatic erythrocytes, suggesting harm to the bone marrow cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genotoxic and cytotoxic effects of testosterone cypionate (deposteron(®)). Meireles, JR., Oliveira, SV., Costa-Neto, AO., et al.[2015]

Testosterone substitution treatment is essential for individuals with irreversible conditions that lower testosterone levels, requiring almost life-long therapy to maintain normal physiological levels.

Long-acting testosterone preparations, such as implants and injectable testosterone undecanoate, are effective options, providing stable testosterone levels for 3-6 months and 12 weeks, respectively, with minimal side effects in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New long-acting androgens. Gooren, LJ.[2018]

Testosterone undecanoate offers a more stable and effective treatment for androgen deficiency compared to traditional injectable testosterone, with injections spaced 12 weeks apart after an initial loading phase, maintaining plasma testosterone levels within the normal range.

This new formulation has an excellent safety profile, showing no adverse effects on blood parameters, lipid profiles, or prostate health, while effectively reversing symptoms of hypogonadism in bone, muscle, and sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone depot injection in male hypogonadism: a critical appraisal. Yassin, AA., Haffejee, M.[2021]

Testosterone undecanoate (TU) is a long-acting injectable testosterone replacement therapy that can be administered only four times a year, providing stable testosterone levels with an excellent safety profile.

Long-term studies, including data from patients treated for over 8 years, show that TU is effective and safe, with no serious side effects reported, making it a desirable option for hypogonadal men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone undecanoate in the treatment of male hypogonadism. Edelstein, D., Basaria, S.[2014]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534853/

Androgen Replacement - StatPearls - NCBI Bookshelf - NIH Testosterone supplementation reduces sperm counts and spermatogenesis. Ten percent of men on testosterone replacement therapy will not recover ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5182226/

Pharmacology of testosterone replacement therapy ... The goal of testosterone replacement therapy (TRT) is to return serum testosterone levels to within physiologic range and improve symptoms in hypogonadal ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf

Depo®-Testosterone testosterone cypionate injection, USP ... There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding. Pharmacokinetics.

4. uspharmacist.com uspharmacist.com/article/a-review-of-testosterone-therapy-options-for-men

A Review of Testosterone Therapy Options for Men Testosterone should be monitored at 14 days and 35 days after treatment initiation or following dose adjustment. The dosing range is 10 mg to 70 ...

5. mayoclinic.org mayoclinic.org/drugs-supplements/testosterone-cypionate-intramuscular-route/description/drg-20563731

Testosterone cypionate (intramuscular route) - Side effects ... Testosterone cypionate injection is use to treat males whose bodies do not make enough natural testosterone, a condition called hypogonadism.

6. aetna.com aetna.com/cpb/medical/data/1000_1099/1014.html

Testosterone Cypionate Injections - Medical Clinical Policy ... Budoff and colleagues (2017) stated that recent studies have yielded conflicting results as to whether testosterone treatment increases cardiovascular risk. In ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/216318s000lbl.pdf

Testosterone cypionate injection - accessdata.fda.gov It is not known if Testosterone Cypionate Injection is safe or effective to treat men who have low testosterone due to aging. • It is not known if ...