Two different posters presented at ENDO 2016 demonstrated positive efficacy in the use of oral testosterone treatments. While one study showed that a twice-daily administration of oral testosterone was effective in improving the psychosexual symptoms in hypogonadal men regardless of the presence of cardiovascular disease, another study revealed that the treatment was safe in the long-term management of hypogonadal subjects.
Both of the studies — “Hypogonadal Men with and without Cardiovascular Disorders Benefit from LPCN 1021 (Oral Testosterone)” and “Long-Term Safety and Tolerability of Oral Testosterone (LPCN 1021) in Hypogonadal Men” — reported their results from the 52-week, phase 3 Study of Androgen Replacement (SOAR) study, a randomized, active-controlled, two-arm, 12-month, open-label, multicenter, dose-titration trial that included 314 hypogonadal men between the ages of 18 and 80 years.
“Long-Term Safety and Tolerability of Oral Testosterone (LPCN 1021) in Hypogonadal Men” demonstrated that LPCN 1021, an investigational oral testosterone replacement therapy that is currently under FDA review, restored testosterone levels in men with hypogonadism who received treatment for up to 52 weeks, according to the study’s lead author, Adrian Sandra Dobs, MD, M.H.S., professor of Medicine and Oncology, The Johns Hopkins University School of Medicine, Baltimore, Md. “This study also assessed the safety profile of LPCN 1021 over the duration of the study vs. the leading topical gel. Notably, no liver function issues were identified in patients who received LPCN 1021. The long-term safety profile suggests that, if approved, LPCN 1021 could fill a significant unmet need for an oral testosterone replacement therapy option that does not carry the risk of inadvertent transference associated with gels.”
“Hypogonadal Men with and without Cardiovascular Disorders Benefit from LPCN 1021 (Oral Testosterone)” suggests that oral LPCN 1021 offers a safe and effective treatment, without some of the concerns associated with other available TRT formulations, such as the risk of inadvertent transference with topical gels or the pain of injections, for hypogonadal men with or without cardiovascular disease, according to Mohit Khera, MD, MPH, director of the Laboratory for Andrology Research at Baylor College of Medicine’s McNair Medical Institute and medical director for the Houston Hospital for Specialized Surgery and Baylor College of Medicine’s Executive Health Program.
“This study assessed the efficacy and safety of LPCN 1021 in men with and without cardiovascular disease,” Khera continues. “It demonstrated that twice-daily oral LPCN 1021 improves psychosexual symptoms in hypogonadal men with or without cardiovascular disease.”
Dobs adds that her study suggests that the safety and efficacy profile of oral LPCN 1021 supports its use as a treatment option for men with hypogonadism. “LPCN 1021 combines testosterone undecanoate and a proprietary delivery system which enables it to be primarily absorbed though the lymphatic system and not the liver to allow absorption and mitigate the risk of hepatic toxicity,” she says.
Although the results of both of these studies seems to show that oral testosterone treatment is an effective alternative to topical treatments without the side-effects, both researchers feel that further studies are needed. “Additional research on LPCN 1021 could further explore dosing frequency,” Dobs says, “as well as head-to-head comparisons to provide more information about the benefits and risks compared with non-oral testosterone replacement therapy options.”
Khera, on the other hand, feels that a larger trial using controls would be helpful: “A larger randomized, placebo-controlled study assessing the effects of LPCN 1021 and cardiovascular risk would be beneficial.”
Loading ...