Effects of 2 mg Chlormadinone Acetate/0.03 mg Ethinylestradiol in Primary Dysmenorrhoea: The BEDY (Belara(R) Evaluation on Dysmenorrhea) Study - an Open, Non-Comparative, Non-Interventional Observational Study with 4,842 Women

Background: This prospective, non-interventional, observational study designed to reflect the daily medical practice which is very important for the product observation liability investigated the effects of 2.0 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) on dysmenorrhoea and related problems. Study design: A total of 4,842 patients were observed during a six-cycle period (26,945.5 treatment cycles) in 608 office-based gynaecological centres throughout Germany. Results: The administration of CMA/EE significantly reduced the number of patients who suffered from menstrual pain (–50.4 %). Analgesic use and absenteeism from school or work due to dysmenorrhoea was reduced by 74.6 % in OC starters and 91.9 % in OC switchers. CMA/EE was well tolerated and provided high contraceptive efficacy, with a non-adjusted Pearl index of 0.289 (95 % confidence interval 0.11–0.63). Significant reductions (p ≤ 0.001, baseline vs. final visit) were also seen in intermenstrual bleeding, bleeding intensity, premenstrual syndrome, mood swings, breast tenderness, headache, acne-prone skin and greasy hair. Conclusions: This evaluation supports previous findings that CMA/EE is an effective, well-tolerated contraceptive, reducing menstrual pain (dysmenorrhoea) significantly. In addition, CMA/EE offers substantial further non-contraceptive benefits. J Reproduktionsmed Endokrinol 2010; 7 (Special Issue 1): 112–18.