Objective: To evaluate the systemic and therapeutic effect of topical
testosterone treatment in vulvar lichen sclerosus. Methods: This prosp
ective clinical, single-arm study included ten postmenopausal women wi
th vulvar lichen sclerosus. Testosterone propionate (0.04 g daily) was
administered topically for 4 weeks. Serum androgens (testosterone, fr
ee testosterone, androstenedione, dehydroepiandrosterone sulfate) were
determined before and after 4 weeks of treatment, and; vulvodynia was
evaluated by a horizontal visual analogue scale. Results: Serum level
s of total testosterone increased in all patients (P < .01) and exceed
ed normal range in eight of ten women. Vulvodynia improved in nine of
ten patients (paired t test: P < .01). Four of ten patients showed cli
nical signs of hyperandrogenism (enlargement of the clitoris, alterati
ons of the voice, increase in libido) after 4 weeks of treatment. The
only patient without subjective improvement had elevated basal serum a
ndrogen levels and showed clinical signs of hyperandrogenism before th
erapy. Conclusion: Topical testosterone is effective in normoandrogeni
c women with lichen sclerosus. Androgen status should be evaluated bef
ore treatment, and dosage should be individualized to avoid virilizati
on and metabolic side effects. Because there is a marked systemic effe
ct, clinical controls and a follow-up with evaluation of serum testost
erone levels are recommended. Other steroids should be included in the
rapeutic decisions. Copyright (C) 1997 by The American College of Obst
etricians and Gynecologists.