Serum testosterone concentration rises in a predictable manner after implantation of extended-release testosterone pellets (Testopel), and the dose response is not impacted by the patient's body mass index.
Researchers from New York University Langone Medical Center, New York, analyzed data from 30 hypogonadal men enrolled in the phase IV, single-center, open-label extension study. Per protocol, testosterone dosage was based on BMI and pretreatment testosterone level and could range from six to 12 pellets. Four patients received eight pellets, 15 were implanted with 10 pellets, and 11 were implanted with 12 pellets.
Serum testosterone levels were measured at baseline and then at 1, 4, 12, and 24 weeks postimplantation; 28 men reached the 24-week follow-up. Mean testosterone level peaked at almost 900 ng/dL after 1 week, remained at therapeutic levels through week 12, and returned to pretreatment levels by week 24.
"The primary analyses from this study have been published [J Sex Med 2011; 8:1186-96] and showed implantation of these long-acting testosterone pellets can provide therapeutic levels of testosterone over several months as well as high patient satisfaction based on preference ratings compared with previous treatments," said first author Matthew Sand, MD, a urology resident at New York University Langone Medical Center.