Randomized Clinical Trial with Testosterone Pellets

Currently, there is much discussion about the safety and efficacy of hormonal implants. Part of this controversy is related to the lack of preparation of some doctors to prescribe and properly follow up with patients using this modality of hormonal replacement.

Currently, there is much discussion about the safety and efficacy of hormonal implants. Part of this controversy is related to the lack of preparation of some doctors to prescribe and adequately accompany patients using this modality of hormonal replacement.

To face these challenges, it is essential for professionals to stay updated and armed with solid arguments to guide their patients and engage in dialogue with other specialists. With this in mind, Renewal maintains Medical Education as one of its fundamental pillars.

In this edition of SottoNews, we highlight the scientific article “Randomized Clinical Trial of Testosterone Replacement Therapy in Hypogonadal Men”, by Ann J. Conway and colleagues, which investigates the efficacy and safety of three routes of testosterone replacement: injectable, oral, and subcutaneous implants (pellets).

Study Methodology

The study was a randomized clinical trial with a crossover design, involving 15 men diagnosed with hypogonadism. Participants were randomly divided into groups to experience, at different times and with “washout” intervals, the three replacement modalities:

1. Intramuscular injections: Testosterone esters (250 mg) every two weeks.
2. Oral route: Testosterone undecanoate (120 mg), administered twice daily.
3. Subcutaneous implants (pellets): Six implants of 100 mg each.

Each treatment phase lasted three months, with “washout” intervals between cycles (4 to 6 weeks). Researchers evaluated:

• Hormonal levels: total and free testosterone, SHBG, estradiol, LH, and FSH.
• Clinical indicators: fatigue, sexual function, mood, and body composition.
• Adverse effects: changes in hematocrit, lipid profile, and liver function.

Results

The results revealed notable differences in the pharmacokinetic profiles and clinical responses of the three administration routes:

• Intramuscular injections: Showed rapid and marked elevations in testosterone levels, followed by progressive declines until the next application. Indicated for quick relief of symptoms but associated with hormonal fluctuations.
• Oral route: Demonstrated variable absorption among patients, with hormonal fluctuations throughout the day. Despite the convenience, it requires careful monitoring of liver function.
• Subcutaneous implants (pellets): Offered more stable testosterone levels, with a lower risk of adverse effects. Only a few patients reported local reactions or expulsion of the implant.

Conclusions

All three modalities proved effective in treating hypogonadism, but there were significant differences:

1. Hormonal stability: Subcutaneous implants maintained more stable hormonal levels and had a lower incidence of adverse effects.
2. Duration of effect: With a total dosage of 600 mg, the implants ensured therapeutic levels for four months. Higher doses (1,200 mg, using 200 mg pellets) may extend the effect up to six months.
3. Customization of treatment: The choice of route should take into account convenience, tolerance, and individual response, with continuous medical follow-up.

This study provides robust evidence for clinical practice, reinforcing the use of testosterone implants as a safe and effective option for patients with hypogonadism. And we, at Renewal, are always on top of all the possible information to update our certified doctors and provide ever more well-being and balance to our patients.

Article written by Dr. Francisco Tostes, Scientific Director at Renewal.