Six-Month Evaluation of the Benefits of the Low-Dose Combined Oral Contraceptive Chlormadinone Acetate 2 mg/Ethinylestradiol 0.03 mg in Young Women

Abstract

Background: In clinical trials and non-interventional studies encompassing >50 000 women, the monophasic, low-dose combined oral contraceptive (OC) chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (CMA/EE) has been shown to have various non-contraceptive benefits, as well as contraceptive efficacy and good tolerability. However, there is a paucity of data on use of this OC in young women.

Objective: To investigate the relevance of, and changes in, cycle disorders, dysmenorrhoea and skin problems in addition to the efficacy and tolerability of CMA/EE in young women.

Methods: In this prospective, observational, non-interventional, multicentre study (TeeNIS [Teenager in Non-Interventional Study 2mg CMA/0.03mgEE]), young women (≤20 years of age) were administered CMA/EE (Belara®) once daily for 21 days (one blister strip), followed by either a 7-day pill-free interval (conventional cycle regimen; 89.3%) or a pill-free interval after two blister strips or more (extended cycle regimen; 3.7%), over a 6-month treatment period. Data on the mode of administration were missing for 7.1% of patients. The study included a safety population of 7462 patients (the efficacy population consisted of 6885 patients) from 886 gynaecological centres throughout Germany.

Results: Compared with baseline, CMA/EE intake resulted in significant reductions in the numbers of patients with cycle disorders, i.e. spotting (−46%), breakthrough bleeding (−64%), heavy bleeding (−95%) and absence of any bleeding (secondary amenorrhoea; −76%) [all p≤ 0.001], and with dysmenorrhoea (−56%) [p≤ 0.001]. Similarly, there was a significant decrease in the number of patients who used analgesics (−75%), had dysmenorrhoea-associated symptoms (back pain [−69%], headache [−70%], nausea/vomiting [−85%], diarrhoea [−80%], mood swings [−75%] or absence from school/job due to dysmenorrhoea [−92%]), or were restricted in their leisure/sporting activities because of dysmenorrhoea (−83%) [all p ≤ 0.001]. Another major benefit of CMA/EE was a significant reduction in the number of patients with skin problems (acne and acne-prone skin) [−55%; p≤ 0.001]. In parallel, the number of patients who needed dermatological treatment (−67%; p≤ 0.001) and concealer cosmetics (−55%; p≤ 0.001) was significantly reduced, and significantly fewer patients felt that their self-esteem was restricted due to skin problems (−67%; p≤ 0.001). There were no relevant weight changes during the observation period; mean bodyweight remained virtually constant (mean weight change <1 kg). At final assessment, physicians’ expectations were either ‘completely fulfilled’ or ‘exceeded’ with regard to cycle stability, regular bleeding, dysmenorrhoea, effects on weight, and skin problems in 78–95% of patients. CMA/EE provided high contraceptive efficacy with an unadjusted Pearl index of 0.25, calculated from 41 601 cycles of exposure; seven out of eight pregnancies were attributable to user failure, thus resulting in an adjusted Pearl index of 0.03. The tolerability of CMA/EE was excellent, with no unexpected adverse effects.

Conclusions: This observational, non-interventional study in young women showed that CMA/EE had a significantly beneficial effect on cycle disorders, dysmenorrhoea and skin disorders, and confirmed the good efficacy and tolerability of this combined OC.