Sebum production and plasma testosterone levels in man after high-dose medroxyprogesterone acetate treatment and androgen administration.

Abstract

Abstract. In 47 healthy male volunteers, the administration of 100 mg of oral medroxyprogesterone acetate daily for 42 consecutive days caused a modest 16.7% decrease in sebum production from a baseline mean of 2.28 mg to a post-treatment mean of 1.90 mg. This represented a considerably smaller decrement than had been reported in the literature. Immediately following the period of medroxyprogesterone acetate administration, the addition of daily oral doses of either 50 mg of fluoxymesterone, methyltestosterone, or calusterone to the 100 mg daily dose of medroxyprogesterone acetate for 42 additional days resulted in the return of sebum production to essentially pre-suppression values. A statistically significant decrease in serum testosterone levels, from a pre-treatment mean of 862 ng/100 ml to a post-treatment mean of 251 ng/100 ml, was seen in all groups treated during the first 42 days with 100 mg of medroxyprogesterone acetate daily (P < 0.05). The addition of 50 mg of fluoxymesterone, methyltestosterone, or calusterone to the 100 mg of medroxyprogesterone acetate for another 42 day period caused a further decrease in serum testosterone levels (P < 0.001); the fluoxymesterone-medroxyprogesterone acetate combination produced the greatest decrease of serum testosterone levels, from a pre-treatment mean value of 932.8 ng/100 ml (Day 1), to a post-treatment mean value of 70.6 ng/100 ml (Day 85). The daily dose of 20 mg of medroxyprogesterone acetate for 42 consecutive days caused less suppression of serum testosterone levels (from 831 ng/100 ml to a mean of 585 ng/100 ml) than 100 mg of medroxyprogesterone acetate (from 831 ng/100 ml to a mean of 214 ng/100 ml), but more than that of placebo (pre-treatment mean of 886 ng/100 ml to a post-treatment mean of 871 ng/100 ml). Except for changes in haemoglobin, haematocrit and haptoglobin values, no other medically significant changes were seen in the routine screening chemistries and urineanalyses for any of the drug groups. These changes were not unexpected, as they are known to occur with androgen therapy. Of potentially clinical importance was the absence of any effect of antithrombin-3 levels during the study period. No major side effects were reported other than in one patient who developed gynaecomastia of his right breast on Day 42 of medroxyprogesterone acetate therapy. After his being removed from the study, the gynaecomastia disappeared rapidly.