Comparison of Diane 35 and Diane 35 plus finasteride in the treatment of hirsutism

Objective: To compare the clinical efficacy of an original combined therapy with cyproterone acetate, 2 mg, and ethinylestradiol, 35 mu g (Diane 35), plus finasteride (5 mg) for 2 weeks per month with that of Diane 35 alone i n hirsute women. Design: Prospective randomized, single-blinded study. Setting: Outpatients in an academic research environment. Patient(s): Fifty women with idiopathic hirsutism (IH) or the polycystic ov ary syndrome (PCOS). Intervention(s): Group 1 (n = 25) received Diane 35 alone and group 2 (n = 25) received Diane 35 plus finasteride. The latter drug was administered us ing a new therapeutic scheme: 14 consecutive days for each therapeutic cycl e. Main Outcome Measure(s): Hormonal evaluation was done before beginning trea tment and after 3 and 6 months of therapy. Hirsutism was graded at 3-month intervals. Result(s): The combination of Diane 35 plus finasteride for 14 days signifi cantly decreased the hirsutism score after 3 months of therapy, while Diane 35 alone induced this effect after 6 months. Conclusion(s): Finasteride in combination with Diane 35 for 14 days is effe ctive, well accepted, and safe in hirsute patients, as the amount of antian drogenic drugs administered is much lower than that in conventional treatme nt.