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 physicians to properly prescribe and monitor patients who use this modality of hormone replacement.

To address these challenges, it is essential that professionals stay updated and equipped with solid arguments to guide their patients and dialogue with other specialists. With this in mind, SottoPelle 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 testosterone replacement routes: injectable, oral, and subcutaneous implants (pellets).

Study Methodology

The study was a randomized clinical trial with 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:

Three Tested 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:

• Hormone 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 marked differences in the pharmacokinetic profiles and clinical responses of the three administration routes:

1. Intramuscular Injections

• Rapid and pronounced elevations in testosterone levels
• Progressive declines until the next application
• Indicated for rapid relief of symptoms
• Associated with hormonal fluctuations

2. Oral Route

• Variable absorption among patients
• Hormonal oscillations throughout the day
• Convenience of administration
• Requires careful monitoring of liver function

3. Subcutaneous Implants (Pellets)

• More stable levels of testosterone
• Lower risk of adverse effects
• Some patients reported local reactions or implant extrusion

Conclusions

The three modalities proved effective in treating hypogonadism, but showed significant differences:

Hormonal Stability

Subcutaneous implants maintained more stable hormone levels and showed lower incidence of adverse effects.

Duration of Effect

• 600 mg dose: Ensured therapeutic levels for four months
• Higher doses (1,200 mg): Using 200 mg pellets can extend the effect for up to six months

Treatment Personalization

The choice of route should consider:

• Convenience for the patient
• Individual tolerance
• Specific response
• Continuous medical monitoring

Clinical Implications

This study provides robust evidence for clinical practice, reinforcing the use of testosterone implants as a safe and effective option for patients with hypogonadism.

Advantages of Pellets

• Superior hormonal stability
• Fewer adverse effects
• Convenience for the patient
• Prolonged duration of effect
• Less need for frequent monitoring

Important Considerations

• Adequate patient selection
• Correct implant technique
• Regular follow-up
• Continuous medical education

And we at SottoPelle Brasil are always up to date with all possible information to update our certified physicians to offer increasingly more well-being and balance to our patients.

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Authored by Dr. Francisco Tostes, Scientific Director of SottoPelle Brasil.