Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial

Background: This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia. Study Design: A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities. Results: At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean+/-S.D.) (39.3+/-6.7 vs. 38.7+/-5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean+/-S.D.) (29.6+/-5.9 vs. 31.1+/-5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean+/-S.D.) was significantly more in the LNG-IUS group (87.4+/-11.3%) compared to the COC group (34.9+/-76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6+/-17.0%) group was significantly more compared to the COC group (2.5+/-93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean+/-S.D.) were noted (from 10.2+/-1.3 to 11.4+/-1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8+/-2.6 to 1.6+/-2.4 days, p=.003). Conclusion: The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC. (C) 2011 Elsevier Inc. All rights reserved.