(303) Patient Satisfaction with Oral Testosterone Undecanoate (Jatenzo) in Men with Previous Testosterone Therapy: An Open-Label Single-Center Phase IV Clinical Trial

Abstract

Abstract Introduction Testosterone therapy is available in multiple delivery systems such as gels and injections; however, oral formulations have been unavailable in the United States due to hepatotoxicity and variable bioavailability. Oral formulations of testosterone are convenient, easy to use, and avoid the problems of other forms of testosterone therapy. Jatenzo (testosterone undecanoate) is a novel US FDA-approved oral testosterone capsule that provides a uniform response in patients with testosterone deficiency. Objective This study evaluates patient satisfaction with Jatenzo in men with a recent history of alternative testosterone therapy. Methods Patients between 18 and 65 years of age with a diagnosis of testosterone deficiency were recruited. Testosterone deficiency was defined as two measurements of serum total testosterone below 300 ng/dL combined with clinical symptoms in accordance with American Urological Association guidelines. Patients were required to have received previous testosterone therapy and completed an adequate washout period prior to starting Jatenzo. The primary outcomes were patient satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9); and changes in testosterone deficiency symptoms, measured by the quantitative Androgen Deficiency in Aging Males (qADAM) questionnaire at the 3- and 6-month intervals relative to baseline. Serum testosterone, PSA, hematocrit, and estradiol were also evaluated at each time point. Results Of the 41 patients recruited into the study, 46% had previously received subdermal pellets, 41% intramuscular injections, 6% transdermal gels, and 7% intranasal gels. Total testosterone levels increased from a baseline after appropriate washout from a mean of 187 ng/dL to 773 ng/dL at 1 month, 434 ng/dL at 3 months, and 397 at 6 months of treatment with Jatenzo. Patient satisfaction with Jatenzo as measured by TSQM-9 improved to 52 and 59.3 at the 3-month and 6-month time points, respectively, relative to 38.5 with previous testosterone therapy. Testosterone deficiency symptoms as measured by qADAM were 34 with Jatenzo and 33.5 with previous testosterone therapy. No significant difference was noted in side effects such as polycythemia or changes in estradiol or PSA. Conclusions Jatenzo appears to provide similar patient satisfaction and similar improvement in testosterone deficiency symptoms relative to other forms of testosterone therapy. In addition, Jatenzo increases serum total serum testosterone to reference range (300 – 1000 ng/dL) in >90% of men without a difference in side effect profile. Disclosure Yes, this is sponsored by industry/sponsor: Clarus Therapeutics Clarification Industry funding only - investigator initiated and executed study