Efficacia clinica di un contraccettivo orale contenente etinilestradiolo e drospirenone nel trattamento dell'iperandrogenismo sintomatico [Effectiveness of an oral contraceptive containing ethinyl-estradiol combined with drospirenone in the treatment of symptomatic hyperandrogenism]

Hirusutism, acne/seborrhoea and alopecia are androgen-dependent conditions responding to various treatments. Oral contraceptives (OCs) are largely used to treat hyperandrogenic women, but are often characterized for side effects, lowering the compliance. Drospirenone (DRSP) appears able in minimizing these effects, amplifying the peripheral antiandrogenic results. Our study objective was to evaluate efficacy and safety of long-term administratign of EE/DRSP in hyperandrogenism therapy and to compare the results with the ones obtained using EE/desogestrel (DSG). Study design was based on two randomized trials: Protocol A compared the clinical performance of an OC containing EE 30 μg/DRSP 3 mg (Group A) with one containing EE 40-30 pg/DSG 25-125 μg (Group B) in the treatment of mild-moderate hyperandrogenism; Protocol B compared the same EE/DRSP pill (Group A) with one containing EE 20 μg/DSG 150 μg (Group B) in maintaining the clinical remission obtained with other specific antiandrogenic drugs in moderate-severe hyperandrogenism. Sixty women in Protocol A (mean age 23.6±5.8 years) received EE/DRSP (Group A) or biphasic EE/DSG (Group B); 60 women in Protocol B (25.4±3.3 years) received EE/DRSP (Group A) or EE/DSG (Group B). Complete blood essays and hormonal evaluation, complete physical and instrumental gynaecological examination, acne/seborrhoea and hirsutism assessment have been performed. Side effects and blood loss have been recorded, to evaluate variations in different groups. In Protocol A a significant reduction was observed in hirsutism with EE/ DRSP after 6 cycles and with biphasic EE/DSG after 9 cycles. Acne/ seborrhoea reduced starting from 6 months in both groups. In Protocol B a control of the symptoms was achieved with EE/DRSP while a light reprise was observed after 9 months with EE/DSG. No reprise of acne/ seborrhoea was reported in both groups. Concluding, EE/DRSP is effective in ameliorating the clinical and hormonal features and the compliance in hyperandrogenic patients, being able and more effective than EE/DSG in maintaining the clinical regression of hyperandrogenic symptoms in patients affected by severe hyperandrogenic symptomatology, previously treated with specific drugs. © Copyright 2006, CIC Edizioni Internazionali, Roma