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Ketoconazole blocks testosterone synthesis.

A Pont, P L Williams, S Azhar

Archives of Internal Medicine

|November 1, 1982

Summary

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Ketoconazole, an antifungal drug, was found to significantly lower testosterone levels in men. This effect was temporary in most cases, but highlights potential endocrine concerns with its use.

Area of Science:

Endocrinology
Pharmacology

Background:

Ketoconazole is an antifungal medication used for mycoses.
Gynecomastia in patients using ketoconazole prompted an investigation into its effects on testosterone production.

Observation:

Oral ketoconazole administration (200-600 mg) in male volunteers caused a significant, temporary decrease in serum testosterone concentrations.
Long-term ketoconazole therapy resulted in transient testosterone reduction, with one case of continuous depression.
In vitro studies demonstrated that ketoconazole blocks testosterone synthesis in rat Leydig cells.

Findings:

Ketoconazole inhibits sterol synthesis in fungi and testosterone production in mammals.
Both basal and gonadotropin-stimulated testosterone production were suppressed by ketoconazole at achievable serum concentrations.

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The observed testosterone depression is dose-dependent and transient in vivo, with potential for continuous depression.

Implications:

The anti-androgenic effects of ketoconazole warrant consideration, especially with higher doses or more frequent administration in clinical trials.
Potential endocrinologic toxicity, such as testosterone depression, may be underestimated due to in vivo "escape" mechanisms.
Further research is needed to fully understand the long-term endocrine consequences of ketoconazole therapy.