Elevate Testosterone Replacement Therapy in Your Practice
Help Address the Men’s Health Crisis
American men are experiencing a population-level decline in testosterone levels2, and healthcare providers like you can help address the issue.
In a 24-year study, researchers noted a substantial age-independent decline in testosterone levels among males in the U.S.2 Since the study’s inception in 1984, researchers found that men born in more recent years have lower testosterone levels than previous generations, with average levels declining by about 1% per year.2
What Does This Mean?
This decline in testosterone is a public health issue, one that speaks directly to the core of men’s health and well-being. Physicians like you are on the frontlines of this crisis. Your knowledge and influence can truly make a difference.
What Can You Do About It?
Talk to your patients about the prevalence of hypogonadism and metabolic health. Encourage testing for total testosterone, free testosterone, and sex hormone binding globulin (SHBG), and be part of the solution with testosterone replacement therapy.
Help Your Patients Be the Hero of Their Lives Again
Prevalence of Low Testosterone
Only 5-10% of men with low testosterone are being treated with testosterone therapy.3
Low T can affect men at any age, including approximately 30% of men older than 45.4
Concerned About the Safety of TRT?
The Safety of Testosterone Replacement Therapy
Insights from the TRAVERSE Study
The TRAVERSE study is the largest randomized clinical trial of testosterone replacement therapy (TRT) to date. It was designed to examine the effects of TRT (topical 1.62% testosterone gel) versus placebo on cardiovascular and prostate health, a long-debated topic within the medical community.
Cardiovascular Health and TRT5
Study Participants
- The TRAVERSE study enrolled 5,246 men aged 45 to 80 with documented hypogonadism and pre-existing or a high risk of cardiovascular disease.
- Patients with preexisting cardiovascular disease: 2,847
- Patients at elevated cardiovascular risk: 2,357
- Baseline median serum testosterone level: 227 ng per deciliter; interquartile range, 188 to 258
Findings from the TRAVERSE Study
- At 12 months, the median increase from baseline in serum testosterone levels was 148 ng per deciliter; interquartile range, 34 to 312 (compared with a median increase of 14 ng per deciliter; interquartile range, −21 to 56 in the placebo group).
- TRT did not increase the risk of major heart problems compared to the placebo group.
- There were no clinically meaningful differences in the incidence of secondary cardiovascular end-point events.
Prostate Health and TRT6
Study Participants
- The TRAVERSE study enrolled 5,246 men aged 45 to 80 with documented hypogonadism and pre-existing or a high risk of cardiovascular disease.
- Men at greater risk of prostate cancer (having prostate-specific antigen (PSA) concentrations greater than 3.0 ng/mL and International Prostate Symptom Score (IPSS) greater than 19) were excluded, leaving a total of 5,204 participants.
Findings from the TRAVERSE Study
- There were no significant differences between testosterone-treated and placebo groups.
- Incidences of high-grade or any prostate cancer were low.
- Incidences of acute urinary retention, invasive surgical procedures, or prostate biopsy between testosterone-treated and placebo groups did not differ significantly.
- Testosterone treatment was associated with a greater increase in PSA levels than placebo at 12 months, but there was no significant between-group difference in PSA levels after month 12.
These findings from the TRAVERSE study help provide a clearer picture of TRT’s safety. All TRT treatments, including KYZATREX, include warnings for increased blood pressure (which can increase risks of having a heart attack or stroke), worsening enlarged prostate signs and symptoms, and increased risk of prostate cancer, among other risks. Monitor patients’ blood pressure during treatment with KYZATREX and check for prostate cancer or any other prostate problems before starting and during treatment with KYZATREX.
References:
- Peterson MD, Belakovskiy A, McGrath R, Yarrow JF. Testosterone deficiency, weakness, and multimorbidity in men. Sci Rep. 2018;8(1):5897. doi:10.1038/s41598-018-24347-6
- Thomas G. Travison TG, Araujo AB, O’Donnell AB, et al., Andre B. Araujo, Amy B. O’Donnell, Varant Kupelian, John B. McKinlay, A Population-Level Decline in Serum Testosterone Levels in American Men, J Clin Endocrinol Metab. January 2007, 92(1):196-202.
- Krakowsky Y, Grober E. Testosterone deficiency – Establishing a Biochemical Diagnosis. EJIFCC. 2015 Mar; 26(2): 105–113.PMID: 27683486; PMCID: PMC4975356. Accessed 9 Feb. 2024.
- Endocrine Society.”Hypogonadism in Men | Endocrine Society.” Endocrine.org, Endocrine Society, 31 January 2024, https://www.endocrine.org/patient-engagement/endocrine-library/hypogonadism. Accessed 2 Feb. 2024.
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023; 389:107-117. DOI: 10.1056/NEJMoa2215025
- Bhasin, S., Travison TG, Araujo AB, O’Donnell AB, et al., Pencina, K. M., et al. (2023). Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(12):e2348692. doi:10.1001/jamanetworkopen.2023.48692