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67th Annual Meeting Abstracts
First Long-Acting Testosterone Undecanoate Injection to Treat Male Hypogonadism: 21-Month Safety and Efficacy Outcomes
Abraham Morgentaler1, Joel M. Kaufman2, Ridwan Shabsigh3, *Martin M. Miner4, *Ronald S. Swerdloff5, *Christina Wang5, *Adrian S. Dobs6
1Harvard Medical School, Boston, MA;2University of Colorado School of Medicine, Denver, CO;3Maimonides Medical Center and Columbia University, New York, NY;4The Warren Alpert Medical School of Brown University, Providence, RI;5David Geffen School of Medicine at UCLA, Los Angeles, CA;6Johns Hopkins University School of Medicine, Baltimore, MD
Introduction:
Pharmacokinetic data up to 24 weeks were previously reported from a phase 3 study of testosterone undecanoate (TU) 750 mg for hypogonadism. This study reports data up to 21 months.
Materials & Methods:
For this multicenter, US-based study, TU 750 mg was injected at initial dose, at week 4, and every 10 weeks thereafter through 84 weeks. Men ≥18 years of age with primary or secondary hypogonadism and screening serum testosterone concentrations <300 ng/dL were eligible. Blood was collected frequently during weeks 14-24 (after third injection) and 24-34 (after fourth injection). Trough testosterone samples were collected at each injection. Safety monitoring included clinical labs, prostate health, and AEs.
Results:
Of 130 patients (mean age, 54 y), >75% completed all injections. Mean 10-week testosterone concentration during weeks 14-24 was 494.6 ng/dL (SD, 141.46 ng/dL). Similar testosterone concentrations across injection intervals, with nearly identical peaks and nadirs, indicated consistent testosterone therapy. Mean trough testosterone concentrations were within normal range (300-1000 ng/dL). Injections were well tolerated. AEs were minor and nonserious; 36.7% experienced at least one possibly treatment-related AE, with acne (6.2%) and increased PSA (5.4%) most common. Three (2.3%) had increased hematocrit and/or hemoglobin, and 2 (1.5%) were diagnosed with prostate cancer during the study.
Conclusions:
TU 750 mg every 10 weeks for 21 months effectively provides consistent testosterone concentrations within normal range, a favorable safety profile, and a high level of patient tolerability.
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