Is Oral Testosterone the New Frontier of Testosterone Replacement Therapy?

Abstract

Male hypogonadism is a condition in which the body does not produce enough testosterone, resulting in symptoms such as depressed mood, decreased sex drive, decreased skeletal muscle, and increased fat mass. Male hypogonadism can be readily treated with many available treatments when clinically indicated. The advent of readily available testosterone therapy has increased the importance of finding the most efficacious and cost-efficient treatment modality to approach these patients. Testosterone is typically administered through intramuscular or subcutaneous injections, topical gels, and oral tablets. The efficacy of testosterone therapy on hypogonadal men has been widely studied. However, there has been little research done comparing each modality against each other. This paper seeks to compare the various modalities of testosterone replacement therapy using various parameters such as the beneficial effects on bone mineral density, skeletal muscle mass, fat mass, and libido while simultaneously weighing the distinct undesirable side effects of each form of administration. Our investigation analyzes the methodology and results of the existing research within this field. It aims to draw a nuanced conclusion about the current standard of care for testosterone replacement therapy. According to our research and statistical analyses, we have concluded that oral administration has shown to be as advantageous as other modalities for male hypogonadism. Currently, injectables are the modality of choice, but with the right improvements, oral administration can potentially overtake injectables and transdermal testosterone as the treatment of choice.

Oral Drug Delivery Systems Applied to Launched Products: Value for the Patients and Industrial Considerations

“…15 In contrast, oral testosterone has a mild side effect profile. 174 In another clinical study, a previous switch from formulations with other dosing routes (subdermal pellets, intramuscular injections, and nasal gels) to oral Jatenzo significantly increased patient satisfaction in TSQM-9 scores. 15 From these data, the intestinal lymphatic DDS have contributed to patient value by reducing adverse effects and increasing compliance and satisfaction.…”

“…Transdermal patches induce allergic contact dermatitis and moderate irritation at their application sites . In contrast, oral testosterone has a mild side effect profile . In another clinical study, a previous switch from formulations with other dosing routes (subdermal pellets, intramuscular injections, and nasal gels) to oral Jatenzo significantly increased patient satisfaction in TSQM-9 scores .…”

“…173 A study comparing clinical reports of oral, intramuscular, and transdermal testosterone formulations showed that all DDS have similar efficacy. 174 The major patient complaint with intramuscular testosterone is pain at the injection site, causing low patient compliance. Oral and transdermal therapy avoids this pain, ensures higher patient compliance, and reduces the number of visits to the clinic.…”

“…A study comparing clinical reports of oral, intramuscular, and transdermal testosterone formulations showed that all DDS have similar efficacy . The major patient complaint with intramuscular testosterone is pain at the injection site, causing low patient compliance.…”

Trans Dermal Testosterone Compared to Intramuscular Testosterone for Young Males with Delayed Puberty: A PRISMA Guided Systematic Review

“…23,24 Though the long-term safety and efficacy of Transdermal testosterone therapy (TRT) for puberty completion and maintenance have not been established, reliable evidence on the use of Transdermal testosterone (TT) for adolescent boys to induce and maintain puberty are emerging. [25][26][27] It is optimal that all kinds of TE therapies for young males are administered and monitored to better mimic the physiologic pubertal development. A critical lack of scientific evidence based guidelines for prescribing transdermal TE for adolescent boys hinders achieving this and the current TRT regimens are based on consensus and expert opinion.…”