Objective: To investigate insulin metabolism and its modifications induced
by the administration of flutamide, a specific antiandrogen compound, in wo
men with idiopathic hirsutism (IH) and in nonobese women with polycystic ov
ary syndrome (PCOS).
Design: Prospective, randomized trial.
Setting: Endocrinological Centre of the Department of Obsterics and Gynecol
ogy, University of Caligari, Caligari, Italy.
Patient(s): Thirty-two women with normal body mass index participated in th
e study: 11 with clinical and hormonal features of PCOS and 21 age- and wei
ght-matched normally cycling women with IH (n = 11) and without IH (n = 10,
controls).
Intervention(s): Each subject with PCOS or IH was assigned randomly to rece
ive either flutamide tablets (250 mg twice a day) or placebo for greater th
an or equal to 5 months. Twelve subjects (6 with PCOS, 6 with IH) received
flutamide and 10 (5 with PCOS, 5 with IH) received placebo. All subjects in
gested 75 g of glucose and then underwent an oral glucose tolerance test (O
GTT), 3-7 days after spontaneous or medroxyprogesterone acetate (5 mg daily
for 5 days)-induced menses. Tn women with PCOS or IH, the OGTT was treated
at the fourth month of treatment.
Main Outcome Measure(s): Easting and OGTT-stimulated levels of glucose, ins
ulin, and C peptide.
Result(s): Both fasting and OGTT; stimulated levels of insulin and C peptid
e were significantly higher in women with PCOS and in those with IH than in
controls. Placebo did not modify parameters of glucose metabolism. Flutami
de was capable of significantly blunting fasting and OGTT-stimulated secret
ion of insulin only in women with III.
Conclusion(s): Hyperinsulinemia exists in women with TH as well as in nonob
ese women with PCOS. Treatment with flutamide can completely reverse hyperi
nsulinemia only in women with IH, which suggests that the efficacy of the d
rug is dependent on peripheral androgen hyperactivity. (Fertil Steril(R) 19
99;72: 448-53. (C) 1999 by American Society for Reproductive Medicine.)