What is the mechanism of action of this treatment?

The most common treatment for testicular hypogonadism is androgen replacement therapy, such as Depo-Testosterone (Testosterone Cypionate). This therapy works by supplementing the body with exogenous testosterone, which compensates for the insufficient endogenous production by the testes. This helps restore normal testosterone levels, thereby improving symptoms like fatigue, low libido, and muscle weakness. For patients with testicular hypogonadism, this is crucial as it directly addresses the hormonal deficiency, improving overall quality of life and physical function.

What side effects are associated with this type of intervention?

Testosterone replacement therapy, such as Depo-Testosterone (Testosterone Cypionate), is commonly used to treat testicular hypogonadism. Known side effects include cardiovascular risks (e.g., increased risk of heart attack and stroke), changes in cholesterol levels, increased risk of prostate abnormalities (e.g., benign prostatic hyperplasia and prostate cancer), erythrocytosis (increased red blood cell count), and potential impacts on mood and behavior (e.g., aggression, mood swings). Regular monitoring by healthcare providers is essential to manage these risks effectively.

What prior FDA approvals exist?

Testicular Hypogonadism is commonly treated with Androgen Replacement Therapy, which involves the administration of testosterone to compensate for low levels of the hormone. Depo-Testosterone (Testosterone Cypionate) is an FDA-approved drug used for this purpose. Other similar FDA-approved testosterone replacement therapies include Testosterone Enanthate and Testosterone Undecanoate. These treatments aim to restore normal testosterone levels, thereby improving symptoms such as fatigue, decreased libido, and muscle weakness.

What other types of research exist?

Promising alternatives to Depo-Testosterone for testicular hypogonadism include: 1) Enzalutamide, which has shown long-term efficacy and safety in hormone-naïve prostate cancer and may be considered for hypogonadism due to its androgen receptor inhibition properties. 2) GnRH antagonists like relugolix, which have demonstrated lower cardiovascular risks compared to GnRH agonists and could be beneficial for patients with cardiovascular concerns. 3) Clomiphene citrate and anastrozole, which have been used to raise testosterone levels in hypogonadal men and may offer a non-testosterone-based approach to managing hypogonadism.

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Androgen Replacement Therapy

Testosterone Replacement for Fatigue in Male Cancer Survivors

Phase 2

Recruiting

Led By Jose M Garcia, MD, PhD

Research Sponsored by Seattle Institute for Biomedical and Clinical Research

Eligibility Criteria Checklist

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

Must have

Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year

Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Summary

This trial is testing a testosterone drug to help young male cancer survivors who feel very tired and have low testosterone. The drug aims to increase their energy, improve sexual function, and make them stronger.

Who is the study for?

This trial is for male cancer survivors aged 18-50 who are in remission for at least a year, experiencing fatigue, and have low testosterone levels. They must be able to consent and not have hormone-dependent cancers. Men with total testosterone below 348 ng/dL or free testosterone under 70 pg/mL may join if they haven't used appetite stimulants in the last six months.

What is being tested?

The study tests whether Depo-Testosterone (testosterone cypionate) can improve fatigue, sexual function, life quality, body composition, muscle strength, and physical activity compared to a placebo in young male cancer survivors with low testosterone.

What are the potential side effects?

Possible side effects of Depo-Testosterone include acne, changes in sex drive or performance, hair loss or growth on the face/body/hands/feet; headache; gum irritation/pain/redness/swelling/tenderness.

Eligibility Criteria

Inclusion Criteria

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

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I am a cancer survivor who has been in remission for at least one year after receiving chemotherapy and/or radiation.

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My cancer is not driven by hormones.

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I am between 18 and 50 years old.

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My testosterone levels are lower than normal for a young man.

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I often feel very tired and my fatigue is severe based on a specific test score.

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You understand the study and agree to participate in it.

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I am a cancer survivor in remission for at least one year after treatment.

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I haven't used appetite stimulants in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 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

Fatigue change

Secondary study objectives

Body composition change

Changes to mood and well-being

Daily physical activity change

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TestosteroneExperimental Treatment1 Intervention

Testosterone undecanoate injection 750 MG/3 ML

Group II: PlaceboPlacebo Group1 Intervention

clinical grade saline 0.9% sodium chloride injection

0 / 8Eligibility 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

The most common treatment for testicular hypogonadism is androgen replacement therapy, such as Depo-Testosterone (Testosterone Cypionate). This therapy works by supplementing the body with exogenous testosterone, which compensates for the insufficient endogenous production by the testes. This helps restore normal testosterone levels, thereby improving symptoms like fatigue, low libido, and muscle weakness. For patients with testicular hypogonadism, this is crucial as it directly addresses the hormonal deficiency, improving overall quality of life and physical function.