Session: SAT 554-583-Male Reproductive Endocrinology & Case Reports
Poster Board SAT-575
Methods: This multicenter, single-arm, open-label study evaluated the effects of TU 750 mg in adult men (>=18 y) with primary or secondary hypogonadism and serum testosterone (T) <300 ng/dL. TU 750 mg (3 mL) was given intramuscularly at baseline, week 4, and every 10 weeks thereafter. After injections 2 to 4, patients completed the M-PGA, which assessed improvement from baseline in confidence/self-esteem, sexual performance, moods/behavior, and overall well-being (scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse); responses were combined into improved (very much, much, minimally), no change, or worsened (very much, much, minimally) categories. Patient satisfaction with TU was also assessed (1=very much satisfied, 2=much satisfied, 3=minimally satisfied, 4=neither satisfied nor dissatisfied, 5=minimally dissatisfied, 6=much dissatisfied, 7=very much dissatisfied); responses were combined into satisfied, neither satisfied nor dissatisfied, and dissatisfied categories. For each M-PGA item, the proportion of patients who reported improvement/satisfaction, no change/neither satisfied nor dissatisfied, or worsening/dissatisfaction were calculated.
Results: 130 men enrolled and 117 completed the M-PGA and were included in the analysis. Patients had a mean (SD) serum total T of 214.6 (70.5) ng/dL at screening; after TU injections 3 and 4, 94.0%–96.2% of men maintained average serum total T of 300–1000 ng/dL. After injections 2 to 4, the majority of men reported symptom improvement from baseline. Men reported improvement from baseline in confidence and self-esteem (injection 2: 54.7%, injection 3: 65.8%, injection 4: 76.9%), satisfaction with sexual performance (injection 2: 55.6%, injection 3: 77.8%, injection 4: 77.8%), general moods and behavior (injection 2: 60.7%, injection 3: 68.4%, injection 4: 79.5%), and overall feeling of well-being (injection 2: 64.1%, injection 3: 70.9%, injection 4: 80.3%). After injections 2 to 4, most men were satisfied with TU treatment (injection 2: 75.2%, injection 3: 85.5%, injection 4: 88.0%).
Conclusions: In this open-label study, the majority of men with primary and secondary hypogonadism using TU 750 mg reported improvement in symptoms and well-being from baseline throughout the course of treatment, and most were satisfied with TU injection. For all M-PGA items, patients reported increasingly better outcomes with subsequent injections of TU. Moreover, TU was generally well tolerated (1).
Disclosure: CCW: Consultant, Endo Pharmaceuticals, Advisory Group Member, Endo Pharmaceuticals, Consultant, Indevus, Consultant, Eli Lilly & Company, Consultant, Clarus. ASD: Advisory Group Member, Endo Pharmaceuticals, Speaker Bureau Member, Endo Pharmaceuticals, Investigator, Endo Pharmaceuticals, Investigator, Clarus, Investigator, Takeda, Investigator, NIH. TMD: Employee, Endo Pharmaceuticals. YC: Employee, Endo Pharmaceuticals. XH: Employee, Endo Pharmaceuticals. EWB: Employee, Endo Pharmaceuticals. JMK: Consultant, Indevus. MMM: Consultant, Endo Pharmaceuticals, Advisory Group Member, Endo Pharmaceuticals, Research Funding, Lifespan RI. RSS: Advisory Group Member, Endo Pharmaceuticals, Consultant, Endo Pharmaceuticals, Consultant, Indevus.
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