MP79-01 PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY: AN OPEN-LABEL, SINGLE-CENTER, PHASE IV CLINICAL TRIAL

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP79-01 PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY: AN OPEN-LABEL, SINGLE-CENTER, PHASE IV CLINICAL TRIAL Marco-Jose Rivero, Rohit Reddy, Akhil Muthigi, and Ranjith Ramasamy Marco-Jose RiveroMarco-Jose Rivero More articles by this author , Rohit ReddyRohit Reddy More articles by this author , Akhil MuthigiAkhil Muthigi More articles by this author , and Ranjith RamasamyRanjith Ramasamy More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone therapy (TTh) is available in multiple modalities. Oral formulations, previously unavailable in the United States due to variable bioavailability, are convenient, easy to use, and free of painful injections. Testosterone undecanoate (TU) is a recently approved oral testosterone capsule that provides a uniform response in patients with testosterone deficiency. In this study, we evaluated patient satisfaction with TU in men with a recent history of alternative TTh. METHODS: Patients between 18 and 65 years of age with a diagnosis of testosterone deficiency were recruited. Testosterone deficiency (TD) was defined as two measurements of serum total testosterone below 300 ng/dL combined with one or more characteristic clinical symptoms. Patients were required to have received previous TTh and completed an adequate washout period prior to starting TU. The primary outcomes were patient satisfaction, measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9); and TD symptom control, measured by the quantitative Androgen Deficiency in Aging Males (qADAM) questionnaire at 3- and 6-month intervals. Routine blood tests were also performed at each time point. RESULTS: Of the 43 patients recruited into the study, 47% had previously received subdermal pellets, 40% intramuscular injections, and 12% intranasal gels. After the appropriate washout period, serum total testosterone levels increased from a baseline mean of 193.4 ng/dL to 747.9 ng/dL at 1 month, 500.6 ng/dL at 3 months, and 692.2 ng/dL at 6 months of treatment with TU. Mean global satisfaction measured by TSQM-9 progressed from 64.1 with previous TTh to 80.2 at 3 months (p=0.011) and 88.8 at 6 months (p<0.001) of treatment with TU. Similar 6-month changes were observed for TSQM-9 measures of effectiveness (p<0.001) and convenience (p<0.001). Mean TD symptom control measured by qADAM at 6 months (35.0) was statistically unchanged from baseline (36.8, p=0.154). No significant changes were noted in hematocrit, prostate-specific antigen, or estradiol throughout the study period. CONCLUSIONS: TU provides patient satisfaction and TD symptom control that is noninferior compared to other forms of TTh. In addition, TU increases serum total testosterone to reference range (300–1000 ng/dL) in >90% of men without a difference in side effect profile over 6 months of treatment. Source of Funding: This project was funded by an investigator-initiated grant provided by Clarus Therapeutics © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1141 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Marco-Jose Rivero More articles by this author Rohit Reddy More articles by this author Akhil Muthigi More articles by this author Ranjith Ramasamy More articles by this author Expand All Advertisement PDF downloadLoading ...