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Which testosterone replacement therapy?

J A Cantrill, P Dewis, D M Large

    Clinical Endocrinology
    |August 1, 1984
    PubMed
    Summary
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    Testosterone replacement therapy comparison shows subcutaneous implants offer the most physiological androgen replacement. Oral testosterone undecanoate may be useful for initial therapy phases.

    Area of Science:

    • Endocrinology
    • Andrology
    • Pharmacology

    Background:

    • Hypogonadism requires testosterone replacement therapy.
    • Various formulations exist, each with distinct pharmacokinetic profiles.
    • Optimal delivery method for sustained and physiological testosterone levels remains under investigation.

    Purpose of the Study:

    • To compare three testosterone (T) replacement therapy methods: intramuscular injection of mixed T esters, subcutaneous implantation of fused T pellets, and oral administration of T undecanoate (TU).
    • To evaluate serum T levels, hormonal variability, and metabolite profiles across different formulations.
    • To assess the physiological relevance and cost-effectiveness of each therapy.

    Main Methods:

    • Three groups of hypogonadal males received different T formulations: intramuscular T esters (250 mg every 3 weeks), subcutaneous T pellets (6 x 100 mg), and oral TU (80 mg twice daily).

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  • Serial serum hormonal estimations were performed over time to assess T levels, oestradiol (E2), and 5 alpha-dihydrotestosterone (DHT).
  • Pharmacokinetic profiles and overall mean T levels were calculated for each group.

    • Main Results:

    • Oral TU showed marked variability in serum T levels due to absorption issues, with a mean T of 12.0 nmol/l.
    • Intramuscular T esters resulted in supraphysiological T peaks (mean 71 nmol/l) followed by decay, with a mean T of 27.7 nmol/l.
    • Subcutaneous T implantation provided gradual T rise and slow decline, maintaining levels within the normal range for 4-5 months (mean T 17.0 nmol/l over 21 weeks).
    • E2 levels remained normal with TU and implants, but peaked post-injection. DHT levels paralleled T, with highest DHT:T ratios for TU.
    • Drug costs were similar for T implantation and injections, but significantly higher for oral TU.

    Conclusions:

    • Subcutaneous testosterone implantation is the most physiological form of androgen replacement therapy, well-accepted with few side effects.
    • Oral testosterone undecanoate may serve a role in the initial stages of therapy.
    • Intramuscular testosterone esters lead to supraphysiological peaks and require frequent administration.