Jatenzo for Low Testosterone

Not currently recruiting at 27 trial locations

Overseen By Khye Hill

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Tolmar Inc.

Must not be taking: Corticosteroids, Glucocorticoids, Atypical antipsychotics, others

Disqualifiers: Panhypopituitarism, AI, Diabetes, 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: 13

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the drug JATENZO affects adrenal function in men with low testosterone over a year. JATENZO aims to help men with hypogonadism, a condition where the body doesn't produce enough testosterone, by increasing testosterone levels. Men previously diagnosed with low testosterone who are not currently on testosterone therapy or are willing to stop their current treatment may be suitable candidates. As a Phase 4 trial, JATENZO has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any current testosterone treatments before joining. If you are on other medications, the protocol does not specify changes, but you should discuss your specific situation with the trial team.

What is the safety track record for JATENZO?

Studies have shown that Jatenzo, a pill for testosterone replacement, offers a safe option for men needing more testosterone due to certain medical conditions. Research indicates that most people tolerate it well, though some may experience side effects like changes in liver function. However, long-term safety information is not yet available. While Jatenzo is approved for specific uses, such as low testosterone not caused by aging, ongoing studies continue to monitor its long-term effects to ensure safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for low testosterone, which often involves topical gels or injectable testosterone, JATENZO is an oral treatment. This makes it unique because it offers a more convenient and potentially less invasive option for patients. Researchers are excited because JATENZO allows for easy dose adjustments based on serum testosterone levels, which might lead to more personalized and effective management of testosterone levels.

What is the effectiveness track record for JATENZO in treating low testosterone?

Research has shown that JATENZO, a pill for boosting testosterone, successfully restores normal testosterone levels in men with low testosterone. In this trial, participants will take JATENZO twice daily, with potential dose adjustments based on serum testosterone levels. Studies found that 87.8% of men taking JATENZO reached normal testosterone levels. Participants also reported improvements in sexual function and mood, similar to other testosterone treatments. Over two years, JATENZO maintained steady testosterone levels without major issues. These results support its effectiveness for treating low testosterone in men. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Men aged 18-65 with low testosterone, diagnosed as hypogonadal, can join this trial. They must not be on any testosterone treatments except the study drug and should have had at least one testosterone level below 300 ng/dL before the study. Participants need good vein access for blood samples and must follow the protocol.

Inclusion Criteria

Subject must be able and willing to provide written informed consent and comply with the trial protocol and procedures

I have good vein access in my arm for treatments.

I am a man aged 18-65 with diagnosed low testosterone.

Exclusion Criteria

Subject with a current or prior history of AI

Subject with specific cortisol levels or baseline CBG outside the reference range

Subject who received drugs as part of another research study within 30 days of initial dose administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JATENZO treatment for approximately 1 year with dose titration based on serum testosterone levels

12 months

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• JATENZO

Trial Overview The trial is testing JATENZO's effects on adrenal function in men with low testosterone over a period of 12 months. It's an open-label safety study, meaning everyone knows they're taking JATENZO and there are no placebos or comparison drugs involved.

How Is the Trial Designed?

Group I: JATENZO® twice daily Experimental Treatment 1 Intervention

Participants receive 237 mg JATENZO twice daily, with the potential to be titrated to a higher or lower dose depending on serum testosterone levels.

Who Is Running the Clinical Trial?

Tolmar Inc.

Lead Sponsor

Trials

5

Recruited

1,400+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Published Research Related to This Trial

In a 24-month study involving 69 hypogonadal men, oral testosterone undecanoate (TU) significantly increased total testosterone levels into the normal range and improved sexual function across multiple domains, indicating its efficacy as a testosterone replacement therapy.

The treatment was found to be safe, with no significant adverse effects on liver function or prostate health, although there were minor increases in blood pressure and hematocrit levels, which remained within acceptable limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. Honig, S., Gittelman, M., Kaminetsky, J., et al.[2023]

Male hypogonadism affects a significant portion of the male population (10-30%) and is often not adequately recognized or treated, highlighting the need for effective treatment options.

JATENZO and TLANDO are the first oral testosterone formulations approved by the FDA, utilizing a unique delivery system that allows for safe absorption without causing liver dysfunction, addressing limitations of traditional testosterone replacement therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. Bhat, SZ., Dobs, AS.[2023]

JATENZO® (testosterone undecanoate) is the first oral testosterone therapy approved by the US FDA for treating testosterone deficiency, addressing the long-standing absence of oral options due to safety concerns like hepatotoxicity.

The article discusses the historical challenges in developing a safe and effective oral testosterone formulation, highlighting how JATENZO® overcomes these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JATENZO®: Challenges in the development of oral testosterone. Patel, M., Muthigi, A., Ramasamy, R.[2022]

Testosterone replacement therapy (TRT) is beneficial for older men with frank hypogonadism, leading to increased muscle mass, strength, and improved sexual function, but its use in men with low testosterone without symptoms remains controversial.

While TRT has established risks such as polycythemia and potential cardiovascular issues, it does not increase the risk of prostate cancer, and recent meta-analysis suggests that intramuscular TRT may have a better cardiovascular risk profile compared to oral or transdermal options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of testosterone may be safer and more effective than transdermal administration for combating loss of muscle and bone in older men. Borst, SE., Yarrow, JF.[2023]

Citations

1. jatenzo.com jatenzo.com/?homepage-cta=patient-reported-outcomes

Patient–reported outcomes A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9835814/

Testosterone Replacement Therapy: A Narrative Review with ... JATENZO led to statistically significant improvement in sexual and mood symptoms (measured usign the PDQ), comparable to topical TRT. Common side effects ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609522017805

Two-Year Analysis of a New Oral Testosterone ... Over 2 years of treatment, this novel oral TU formulation maintained total T concentrations in mideugonadal ranges, with improvements in sexual function and no ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01765179

Safety and Efficacy Trial of Testosterone Undecanoate The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men. Official Title.

5. urologytimes.com urologytimes.com/view/published-data-show-safety-efficacy-of-testosterone-undecanoate-in-hypogonadism

Published data show safety, efficacy of testosterone ... Data showed that 87.8% of treated patients and 96.1% of patients who completed the study achieved normal 24-hour mean plasma testosterone values (222 to 800 ng ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/206089s009lbl.pdf

Jatenzo - accessdata.fda.gov It is not known if JATENZO is safe or effective to treat men who have low testosterone due to aging. It is not known if JATENZO is safe or effective in children ...

7. jatenzo.com jatenzo.com/resources-faqs/

JATENZO FAQs - Patient Resources & Downloadable ... Men 18 years and over who have low or no testosterone due to certain medical conditions. JATENZO is not indicated for use in women or men with breast cancer or ...

8. jatenzohcp.com jatenzohcp.com/clinical-safety/

JATENZO Safety Profile Information For HCPs - Trial Results Discover the safety profile of JATENZO, including adverse effects observed during the testosterone replacement study, and its impact on the liver.

9. jatenzo.com jatenzo.com/oral-testosterone-safe-effective/

Designed to offer safe oral delivery of testosterone 1,3 Safety and efficacy of JATENZO in men with low testosterone due to age and in boys less than 18 years old have not been established. JATENZO is a controlled ...