Testosterone for Testicular Hypogonadism

Not yet recruiting at 5 trial locations

Overseen By Balraj Sangha

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Azurity Pharmaceuticals

Must not be taking: Anticoagulants

Disqualifiers: Prostate cancer, Breast cancer, Heart failure, Stroke, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a testosterone injection (Testosterone Cypionate Injection) to determine its effect on blood pressure in men with low testosterone levels, a condition known as hypogonadism. Researchers aim to learn how the treatment changes blood pressure over time. Men diagnosed with hypogonadism and testosterone levels below a certain threshold might be suitable for this trial. Participants should not currently be on testosterone therapy or should have discontinued it for a while. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stop any current testosterone or androgen therapy and complete a washout period (time without taking certain medications) of 45 days or 5 half-lives of the drug, whichever is longer, before starting the study. If you are on a stable dose of antihypertensive or glucocorticoid medications, you can continue taking them during the study.

What is the safety track record for Testosterone Cypionate Injection?

Research has shown that Testosterone Cypionate Injection is generally safe for men with low testosterone levels, a condition known as hypogonadism. One study confirmed its safety, indicating no major concerns that should stop its use. However, possible side effects include increased red blood cell levels, swelling, and heart or liver problems.

Another study highlighted that testosterone therapy can increase muscle mass and strength in healthy men with low testosterone. This suggests the treatment is not only effective but also well-tolerated by many.

As this is a Phase 4 trial, the treatment has already been approved for similar conditions, indicating a strong safety record. Participants should still be monitored for side effects, but existing data remains reassuring. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Testosterone Cypionate Injection is unique because it provides a direct hormone replacement for individuals with testicular hypogonadism, a condition where the body doesn't produce enough testosterone. Unlike other treatments that might focus on stimulating the body's testosterone production, like clomiphene citrate or hCG injections, Testosterone Cypionate directly supplements the hormone, which can lead to more immediate improvements in symptoms like energy, mood, and muscle mass. Researchers are excited about this treatment because it offers a straightforward and potentially quicker way to address testosterone deficiency, improving patients' quality of life more rapidly.

What is the effectiveness track record for Testosterone Cypionate Injection in treating testicular hypogonadism?

Research has shown that testosterone cypionate injections effectively increase testosterone levels in men who need it. This treatment alleviates symptoms such as low energy, decreased muscle mass, and reduced sexual desire. Studies have found improvements in pain sensitivity, increased sexual desire, and enhanced body composition. In one study, men receiving this therapy reported a better quality of life. This treatment is already approved for conditions related to low testosterone, demonstrating its effectiveness in managing these symptoms. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

Men aged 18-75 with low testosterone levels (below specific thresholds) and a BMI between 17 to less than 40. They must have stable blood pressure, not be on high doses of glucocorticoids, and either haven't taken testosterone therapy or have stopped it long enough for a washout period. The study is not suitable for those who don't meet these criteria.

Inclusion Criteria

My BMI is between 17 and 40.

I am willing and able to sign a consent form for the study.

I can understand and follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Testosterone Cypionate Injection and undergo 24-hour Ambulatory Blood Pressure Monitoring

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone Cypionate Injection

Trial Overview

The trial tests the effects of Testosterone Cypionate Injection on blood pressure in men with low testosterone. It's an open-label study where all participants receive the injection and their blood pressure is monitored over 24 hours to see any changes from before treatment.

How Is the Trial Designed?

Group I: Testosterone Cypionate Injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Azurity Pharmaceuticals

Lead Sponsor

Trials

3

Recruited

240+

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5182238/

Adult-onset hypogonadism: evaluation and role of ...

Testosterone enanthate 200 mg administered intramuscularly every 2 weeks achieves normal physiologic testosterone levels for 72% of the treatment interval ...

2.

liebertpub.com

liebertpub.com/doi/10.1089/andro.2021.0024

Comparison of Patterns of Use and Clinical Outcomes ...

This study compared treatment patterns and health outcomes in men using injection TTh with long-acting testosterone undecanoate (TU) injection versus short- ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03792477

A Bioequivalence Study of Testosterone Cypionate in ...

This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated ...

4.

academic.oup.com

academic.oup.com/jcem/article/103/5/1715/4939465

Testosterone Therapy in Men With Hypogonadism

In one RCT in men with opioid-induced T deficiency, T administration improved pain sensitivity, sexual desire, body composition, and some aspects of quality of ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2023/216318Orig1s000MultidisciplineR.pdf

center for drug evaluation and research - accessdata.fda.gov

Testosterone cypionate injection is an androgen indicated for testosterone replacement therapy in males for conditions associated with a ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3897047/

Risks of testosterone replacement therapy in men - PMC

Men on TRT should be monitored for side-effects such as polycythemia, peripheral edema, cardiac and hepatic dysfunction. Keywords: Hypogonadism, side-effects, ...