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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY
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<blockquote data-quote="Nelson Vergel" data-source="post: 251721" data-attributes="member: 3"><p>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</p><p></p><p>Marco-Jose Rivero, R. Reddy, +1 author R. Ramasamy</p><p>Published 1 April 2023</p><p>Medicine, Biology</p><p>The Journal of Urology</p><p></p><p>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. </p><p></p><p>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 3and 6-month intervals. Routine blood tests were also performed at each time point. </p><p></p><p>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). <strong>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.</strong> </p><p></p><p>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.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 251721, member: 3"] 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 Marco-Jose Rivero, R. Reddy, +1 author R. Ramasamy Published 1 April 2023 Medicine, Biology The Journal of Urology 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 3and 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). [B]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.[/B] 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. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
PATIENT SATISFACTION WITH ORAL TESTOSTERONE UNDECANOATE IN TESTOSTERONE-DEFICIENT MEN WITH PREVIOUS TESTOSTERONE THERAPY
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