Introduction: Testosterone deficiency (TD) is defined by an insufficient production of testosterone (T) combined with symptoms such as decreased libido. Multiple delivery systems such as gels and injections are currently available; however, oral formulations have been unavailable in the United States due to hepatoxicity and variable bioavailability. Oral formulations of T are convenient, easy to use, and avoid the problems of other forms of testosterone therapy (TT) such as painful injections and transference. Jatenzo® is a novel US FDA approved formulation of oral T undecanoate that provides a uniform response. In this study, we evaluated patient satisfaction of Jatenzo® as compared to other forms of T. We hypothesize Jatenzo® will have similar patient satisfaction compared to other forms.
Methods: Qualifying patients between ages 18 and 65 with TD symptoms and two T levels <300ng/dL were recruited into this 26-week single-center open-label non-randomized phase IV clinical trial. Patients were required to previously have received TT, completed an adequate washout period, and then were started on Jatenzo®. The primary outcome was Treatment Satisfaction Questionnaire for Medication (TSQM-9), a validated questionnaire for medication satisfaction, as well as changes in TD symptoms as measured by the quantitative Androgen Deficiency in the Aging Male (qADAM) questionnaire at the 3 and 6 month intervals compared to baseline. Serum T, PSA, hematocrit, and estradiol were also evaluated at each time point.
Results: Of the patients recruited, 53% were previously on subdermal pellets, 27% on intramuscular injections, 13% on dermal gels, and 7% on nasal gels. T levels increased from a baseline mean of 201 ng/dL to 686 ng/dL at 1 month and 527 ng/dL at 3 months. Patient satisfaction as measured by TSQM-9 remained similar on oral T undecanoate at 38.3 compared to 39.3 on the prior TT. TD symptoms as measured by qADAM were also similar at 34 compared to 33.5 on prior TT. No significant difference was noted in side effects such as polycythemia or changes in estradiol and PSA.
Conclusions: Oral T undecanoate appears to provide similar patient satisfaction and similar improvement in TD symptoms as other forms of TT. In addition, it increases serum total T to the normal range (300 – 1000ng/dL) in > 90% of men without a difference in side effect profile.
Source of Funding: Investigator-initiated grant provided by Clarus Therapeutics to RR. Trial registration: NCT04983940. Registered 30 July 2021. https://clinicaltrials.gov/ct2/show/NCT04983940