Jatenzo for Low Testosterone

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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months.

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 data supports the effectiveness of the drug JATENZO for low testosterone?

Research shows that JATENZO, an oral testosterone undecanoate, is effective for treating low testosterone in men, providing a safe option without liver damage. It addresses limitations of other testosterone therapies and has been approved by the FDA as a viable oral treatment. ^{1 2 3 4 5}

Is Jatenzo safe for human use?

Jatenzo, an oral testosterone treatment, has been approved by the FDA and is considered a safe option without evidence of liver dysfunction. However, like other testosterone therapies, it may have risks such as cardiovascular issues, and more research is needed to fully understand its long-term safety. ^{1 2 3 5 6}

How is the drug Jatenzo different from other treatments for low testosterone?

Jatenzo is unique because it is the first oral testosterone formulation approved by the FDA, offering a convenient alternative to gels, patches, and injections. It uses a special delivery system that allows for safe absorption without causing liver damage, which was a concern with previous oral testosterone options. ^{1 2 3 7 8}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. Netherlands 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. [2023]

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

JATENZO®: Challenges in the development of oral testosterone. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Testosterone therapy for human immunodeficiency virus-positive men with and without hypogonadism. [2019]

5. China pubmed.ncbi.nlm.nih.gov

Selective androgen receptor modulators for the treatment of late onset male hypogonadism. [2021]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Emerging drugs for hypogonadism. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Effect of testosterone preparations on the function of the hypothalamic pituitary axis in Klinefelter's syndrome]. [2014]