Patient Global Assessment of Testosterone Undecanoate (750 mg) Injections for Testosterone Replacement Therapy in Hypogonadal Men

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 554-583-Male Reproductive Endocrinology & Case Reports
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-575
Christina CL Wang*1, Adrian S. Dobs2, Theodore M. Danoff3, Yusong Chen3, Xiaojun Hu3, Edwin W. Bittner3, Joel M. Kaufman4, Martin M. Miner5 and Ronald S. Swerdloff6
1Harbor - UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, 2Johns Hopkins University School of Medicine, Baltimore, MD, 3Endo Pharmaceuticals Inc, Malvern, PA, 4Urology Research Options, Castle Rock, CO, 5Brown University and The Miriam Hospital, Providence, RI, 6Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA
Objective: Psychosexual symptoms of androgen deficiency may include loss of libido or erectile function, depressed mood, and decreased sense of vitality. In this phase 3 study, men receiving testosterone undecanoate (TU) evaluated hypogonadal symptoms and well-being using the Male–Patient Global Assessment (M-PGA).

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).

(1) Wang C, et al. J Androl. 2010;31:457-465

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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Sources of Research Support: This research was supported by Endo Pharmaceuticals Inc.