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Ketoconazole therapy: hormonal and clinical effects in non-tumoral hyperandrogenism

Vidal-Puig AJ, Muñoz-Torres M, Jódar-Gimeno E, García-Calvente CJ, Lardelli P, Ruiz-Requena ME, Escobar-Jiménez F. Ketoconazole therapy: hormonal and clinical effects in non-tumoral hyperandrogenism. Eur J Endocrinol 1994;130:333–8. ISSN 0804–4643.

The aim of this study was to assess the usefulness of ketoconazole as a therapeutic alternative to polycystic ovary syndrome. The study group comprised 37 women with signs of hyperandrogenism (hirsutism, acne) and oligomenorrhea. A low dose (400 mg/day) of ketoconazole was tested in a 9-month prospective clinical study. Clinical response (Ferriman & Gallway score, acne) and modifications in hormone pattern (luteinizing hormone, follicle-stimulating hormone, estradiol, testosterone, prolactin, 17-hydroxy-progesterone, androstenedione, steroid hormone-binding globulin, dehydroepiandrosterone sulfate, cortisol, adrenocorticotropin (ACTH) and free testosterone index) were measured, and ACTH stimulation tests were performed. Tolerance and side-effects also were assessed. After 9 months of ketoconazole treatment, the patients' Ferriman & Gallway scores (18.26 ± 4.6 vs 12.4 ± 4.1; p < 0.001) and acne had improved markedly. Hormone patterns also became more favorable, with decreases in androgenic steroids (testosterone, androstenedione, free testosterone index and dehydroepiandrosterone sulfate; p < 0.01) and increases in estradiol (p < 0.01). Basal cortisol levels and cortisol after ACTH stimulation were not changed significantly, remaining within the reference range. Increases in ACTH were observed only in the 3rd month (p < 0.01). Initial levels of androgenic steroids were correlated inversely with their percentage decrease in successive samplings. Decreases in adrenal androgenic steroids were associated with an increase in steroid hormone-binding globulin. The side-effects of treatment, although not severe, caused some discomfort and led to a high drop-out rate (30%). Our results suggest that low doses of ketoconazole (400 mg/day) are an alternative therapy for non-tumoral hyperandrogenism, although the bothersome side-effects, which require close monitoring and maximal patient compliance, make this treatment advisable only in selected patients.

Manuel Muñoz-Torres, Plaza Isabel la Católica no. 2, E-18009, Granada, Spain

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