Combined oral contraceptive prescription patterns for therapeutic purposes: results from a subanalysis of the multinational PRO-E2 study.

Purpose: To investigate prescription for therapeutic purposes of combined oral contraceptives (COCs) in countries of the PRO-E2 study, with a special focus on Italy.

Methods: Therapeutic reasons for prescription of COCs currently approved with no therapeutic the sole contraceptive indication, such as associations of nomegestrol acetate plus oestradiol and levonorgestrel plus ethynylestradiol, were investigated in the overall population (Italy excluded) (n = 71,630) and, separately, the Italian subpopulation (n = 19,683) of PRO-E2 study.

Results: COC prescription for contraception only was 38.8% in Italy and 60.8% in the overall population (mainly European countries) (OR = 0.409; 95%CI:0.396-0.423; p < 0.0001). COCs were prescribed for therapeutic purposes and contraception in 44.2% of the Italian subpopulation and 30.2% of the overall population (OR = 1.809; 95%CI:1.752-1.869; p < 0.0001). More women in Italy than the overall population received COCs only for therapeutic purposes (16.7% vs. 6.9%, respectively; OR = 2.694; 95%CI:2.570-2.824; p < 0.0001). Problems related to menstruation, particularly in women aged below 20 or above 40 years, were the most important driver for COC therapeutic use.

Conclusion: COCs are extensively used for therapeutic purposes, mostly to manage menstruation-related disorders. This is particularly evident among Italian prescriptions. The widespread therapeutic use of COCs that are licenced only for contraception indirectly proves their efficacy and the need of a formal recognition of their properties.