Male hypogonadism is the medical term for low testosterone (the main male sex hormone). Historically, oral testosterone was not used to treat male hypogonadism due to the risk of hepatotoxicity, or damage to the liver. However, two oral testosterone formulations have now been approved by the FDA, and several other formulations seem to be on the horizon.
The symptoms of male hypogonadism vary among patients, depending on when they acquire it and the severity of their testosterone deficiency. Boys and young adults with this condition might see a delay or absence of usual physical changes during puberty, including deepening voice, facial and body hair growth, muscle development, and the growth of the penis and testicles. Adults with male hypogonadism may experience erectile dysfunction (ED), decreased sex drive and energy, low sperm count, depression, loss of muscle mass or strength, loss of facial or body hair, increased body fat, osteoporosis (loss of bone mass), and/or enlargement of breasts.
Health care providers treat male hypogonadism with testosterone replacement therapy with the goal of getting a patient’s testosterone levels back within the normal range. Currently, individuals can take testosterone in several ways including injections, implants, gels that are applied to the upper arm, shoulder, or thighs, patches placed on the thighs, torso, or gums, and nasal applications of gel. Soon, oral testosterone treatment options may also become more widespread.
In a recent pharmaceutical study of men with male hypogonadism between the ages of 18-65, researchers tested the safety and efficacy of a new oral testosterone soft gelatin capsule. The participants of the trial had to have one or more symptoms associated with male hypogonadism and could not be taking other forms of testosterone at the time of the study. They completed 3 months (90 days) of treatment, and then their health was monitored by professionals for 9 months during the safety evaluation period.
The manufacturer of the oral testosterone capsules (Marius Pharmaceuticals) reported that more than 96% of the patients who completed 90 days of treatment achieved testosterone levels within the normal range, and the most common negative side effect was high blood pressure. Based on these results, the FDA has accepted a new drug application for this oral testosterone and approved a 6-month extension for the trial. Time will tell if the FDA will approve this new oral testosterone treatment option for male hypogonadism, but the initial results are promising.
Resources:
Broderick, J.M. (2021, March 11). FDA accepts application for novel testosterone replacement therapy for hypogonadism. Urology Times. https://www.urologytimes.com/view/fda-accepts-application-for-novel-trt-for-hypogonadism
Davis, K. (2017, Nov. 23). What you need to know about male hypogonadism. Medical News Today. https://www.medicalnewstoday.com/articles/307634
Mayo Clinic. (2019, Nov. 5). Male Hypogonadism – Symptoms and Causes. https://www.mayoclinic.org/diseases-conditions/male-hypogonadism/symptoms-causes/syc-20354881#:~:text=Overview,often%20from%20injury%20or%20infection
