Effects of Oral Contraceptives Containing Ethinylestradiol with Either Drospirenone or Levonorgestrel on Various Parameters Associated with Well-Being in Healthy Women A Randomized, Single-Blind, Parallel-Group, Multicentre Study

Background: The combined oral contraceptive Yasmin (R) (drospirenone 3 mg plus ethinylestradiol 30 mu g [DRSP 3 mg/EE 30 mu g]) has been shown to be a well tolerated and effective combination that provides high contraceptive reliability and good cycle control. Furthermore, DRSP 3 mg/EE 30 mu g has been shown to have a positive effect on premenstrual symptoms and well-being/health-related quality of life, and to improve the skin condition of women with acne. To date, however, there have been relatively few studies that have compared the effects of DRSP 3 mg/EE 30 mu g on the general wellbeing of women with those of other oral contraceptives. Objectives: To compare the impact of DRSP 3 mg/EE 30 mu g with that of levonorgestrel 150 mu g/EE 30 mu g (LNG 150 mu g/EE 30 mu g; Microgynon (R) 30) on various parameters associated with well-being in healthy female subjects. Methods: This was a randomized, single-blind, parallel-group, multicentre study conducted using 21/7-day regimens of DRSP 3 mg/EE 30 mu g and LNG 150 mu g/EE 30 mu g over seven cycles. Efficacy parameters included: changes in Menstrual Distress Questionnaire (MDQ) normative T scores; the proportion of subjects with acne; and menstrual symptoms. Cycle control and subjective well-being parameters were also assessed. Results: Treatment with DRSP 3 mg/EE 30 mu g had similar beneficial effects on symptoms of water retention and impaired concentration to LNG 150 mu g/EE 30 mu g, but was significantly better in alleviating negative affect symptoms during the menstrual phase (median difference in MDQ T score 3; p = 0.027; Wilcoxon rank sum test). The proportion of subjects with acne decreased from approximately 55% to approximately 45% in the DRSP 3 mg/EE 30 mu g group, but remained static at approximately 60% in the LNG 150 mu g/EE 30 mu g group. Somatic and psychological symptoms occurred at the greatest intensity and for most subjects during the menstrual phase of the cycle in both groups. Both drugs had similar cycle control parameters with a tendency towards reduced bleeding with continued use. More subjects in the DRSP 3 mg/EE 30 mu g group reported improved physical well-being (60% vs 46%; p = 0.035; chi-squared [chi(2)] test). Emotional well-being was reported improved in 61% and 51% of DRSP 3 mg/EE 30 mu g and LNG 150 mu g/EE 30 mu g users, respectively (p=0.1190; chi(2) test). Adverse events were typical of oral contraceptive use and did not give rise to any safety concerns. Conclusion: Both products had similar beneficial effects on symptoms of water retention and impaired concentration, but DRSP 3 mg/EE 30 mu g was significantly better in alleviating negative affect symptoms during the menstrual phase. The proportion of subjects with acne decreased in the DRSP 3 mg/EE 30 mu g group but not in the LNG 150 mu g/EE 30 mu g group. More subjects in the DRSP 3 mg/EE 30 mu g group reported improved physical wellbeing compared with the LNG 150 mu g/EE 30 mu g group.