madman
Super Moderator
Patient Satisfaction After Switching to Jatenzo (Oral Testosterone Undecanoate): Update on an Open-label, Single-arm Clinical Trial (2022)
Rohit Reddy, Marco-Jose Rivero, Mehul Patel, Akhil Muthigi, Ranjith Ramasamy, Parris Diaz
1. Introduction
Testosterone deficiency (TD) is defined as inadequate testicular production and appears to affect at least 5% of men aged ≥ 30 yr [1–3]. TD results in clinical signs and/or symptoms of losses in lean muscle mass [4], bone mineral density [5], anemia [6], energy, and sexual function [7,8].
Patients with TD are candidates for testosterone therapy (TTh). Oral formulations are convenient and easy to use and avoid the side effects of other forms of TTh such as subcutaneous implantation, intramuscular injections, and skin-to-skin transference.
Jatenzo, a testosterone undecanoate (TU) capsule (Clarus Therapeutics, Northbrook, IL, USA), received US Food and Drug Administration (FDA) approval in 2020 and can safely restore patients with low testosterone to the reference range [9]. Historically, oral TTh formulations were linked to liver toxicity and the lowering of high-density lipoprotein cholesterol. However, TU involves a unique self-emulsifying system that leads to greater lymphatic absorption and bypasses first-pass hepatic metabolism [10]. Patient satisfaction with this new form of TTh has yet to be investigated. We report data from a prospective, single-arm, open-label clinical trial evaluating satisfaction with Jatenzo among patients with TD previously treated with other forms of TTh.
4. Discussion
This is the first study investigating patient satisfaction among men receiving oral TU who were previously using other forms of TTh. Over the course of the trial, oral TU appeared to lead to greater patient satisfaction in comparison to previous TTh modalities and a similar improvement in hypogonadal symptoms. In addition, oral TU increased serum total testosterone to the normal range (300–1000 ng/dl) in >90% of the men without a difference in the side effects profile. While the study features of close bloodwork follow-up and mandatory titration allowed for medical optimization, twice-daily doses were far more frequent for the oral form in comparison to intramuscular and pellet therapies and posed a higher risk of missed doses and poorer compliance. Beyond the results from this trial, future studies should investigate patient satisfaction and side effects profiles in a larger population to support practical adoption by patients and practitioners
Rohit Reddy, Marco-Jose Rivero, Mehul Patel, Akhil Muthigi, Ranjith Ramasamy, Parris Diaz
1. Introduction
Testosterone deficiency (TD) is defined as inadequate testicular production and appears to affect at least 5% of men aged ≥ 30 yr [1–3]. TD results in clinical signs and/or symptoms of losses in lean muscle mass [4], bone mineral density [5], anemia [6], energy, and sexual function [7,8].
Patients with TD are candidates for testosterone therapy (TTh). Oral formulations are convenient and easy to use and avoid the side effects of other forms of TTh such as subcutaneous implantation, intramuscular injections, and skin-to-skin transference.
Jatenzo, a testosterone undecanoate (TU) capsule (Clarus Therapeutics, Northbrook, IL, USA), received US Food and Drug Administration (FDA) approval in 2020 and can safely restore patients with low testosterone to the reference range [9]. Historically, oral TTh formulations were linked to liver toxicity and the lowering of high-density lipoprotein cholesterol. However, TU involves a unique self-emulsifying system that leads to greater lymphatic absorption and bypasses first-pass hepatic metabolism [10]. Patient satisfaction with this new form of TTh has yet to be investigated. We report data from a prospective, single-arm, open-label clinical trial evaluating satisfaction with Jatenzo among patients with TD previously treated with other forms of TTh.
4. Discussion
This is the first study investigating patient satisfaction among men receiving oral TU who were previously using other forms of TTh. Over the course of the trial, oral TU appeared to lead to greater patient satisfaction in comparison to previous TTh modalities and a similar improvement in hypogonadal symptoms. In addition, oral TU increased serum total testosterone to the normal range (300–1000 ng/dl) in >90% of the men without a difference in the side effects profile. While the study features of close bloodwork follow-up and mandatory titration allowed for medical optimization, twice-daily doses were far more frequent for the oral form in comparison to intramuscular and pellet therapies and posed a higher risk of missed doses and poorer compliance. Beyond the results from this trial, future studies should investigate patient satisfaction and side effects profiles in a larger population to support practical adoption by patients and practitioners
