Testosterone Replacement Therapy for Low Testosterone

Recruiting in Palo Alto (17 mi)

Overseen by Kenneth Ogan, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Emory University

Must not be taking: Anabolic steroids

Disqualifiers: Prostatectomy, Orchiectomy, Pituitary disorders, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 testosterone replacement therapy generally safe for humans?

Testosterone replacement therapy, particularly with testosterone undecanoate, has an excellent safety profile, maintaining normal testosterone levels without significant side effects. However, high doses of testosterone cypionate have shown genotoxic (DNA-damaging) and cytotoxic (cell-damaging) effects in mice, indicating potential risks at high doses. ^{1 2 3 4 5}

Research Team

Kenneth Ogan, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Testosterone Cypionate (Hormone Therapy)

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.

Participant Groups

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+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Genotoxic and cytotoxic effects of testosterone cypionate (deposteron(®)). [2015]

2. England pubmed.ncbi.nlm.nih.gov

Testosterone undecanoate in the treatment of male hypogonadism. [2014]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Two Sustained Release Membranes Used in Formulating Low Strength Testosterone Reservoir Transdermal Patches. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

New long-acting androgens. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]