BACKGROUND: We compared the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with cyclic oral medroxyprogesterone acetate (MPA) on hemoglobin and serum ferritin levels in women with heavy menstrual bleeding (HMB). STUDY DESIGN: This was a multicenter, randomized study assessing the efficacy of the LNG-IUS and oral MPA (10 mg/day for 10 days) in women with confirmed HMB over 6 cycles of treatment. We previously reported that treatment with the LNG-IUS resulted in greater menstrual blood loss reduction than MPA. In this analysis, hemoglobin and serum ferritin levels were assessed at baseline, Cycle 3, and at Cycle 6, and the relative improvement on treatment was subjectively rated by investigators and women. RESULTS:One hundred and sixty-five women were randomized (82 LNG-IUS/83 MPA). Increases in median hemoglobin levels from baseline to Cycle 6 (7.5% vs. 1.9%; p<.001) and median serum ferritin levels (68.8% vs. 14.3%; p<.001) were greater in the LNG-IUS group than in the oral MPA group. Baseline median hemoglobin and ferritin levels were 12.4 g/dL and 19.0 mcg/L with the LNG-IUS and 12.2 g/dL and 19.0 mcg/L with oral MPA, respectively. At Cycle 6, the corresponding medians were 13.4 g/dL and 34.0 mcg/L with the LNG-IUS and 12.6 g/dL and 21.0 mcg/L with oral MPA. At Cycle 6, the proportion of women who rated their bleeding as 'improved' was higher with the LNG-IUS than with oral MPA, both according to investigator assessment (93.6% vs. 61.0%) and self-assessment (93.6% vs. 67.1%). CONCLUSIONS: Women treated with the LNG-IUS had greater increases in median hemoglobin and serum ferritin levels, and higher rates of subjective improvement than women treated with oral MPA.
RCT Entities:
BACKGROUND: We compared the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with cyclic oral medroxyprogesterone acetate (MPA) on hemoglobin and serum ferritin levels in women with heavy menstrual bleeding (HMB). STUDY DESIGN: This was a multicenter, randomized study assessing the efficacy of the LNG-IUS and oral MPA (10 mg/day for 10 days) in women with confirmed HMB over 6 cycles of treatment. We previously reported that treatment with the LNG-IUS resulted in greater menstrual blood loss reduction than MPA. In this analysis, hemoglobin and serum ferritin levels were assessed at baseline, Cycle 3, and at Cycle 6, and the relative improvement on treatment was subjectively rated by investigators and women. RESULTS: One hundred and sixty-five women were randomized (82 LNG-IUS/83 MPA). Increases in median hemoglobin levels from baseline to Cycle 6 (7.5% vs. 1.9%; p<.001) and median serum ferritin levels (68.8% vs. 14.3%; p<.001) were greater in the LNG-IUS group than in the oral MPA group. Baseline median hemoglobin and ferritin levels were 12.4 g/dL and 19.0 mcg/L with the LNG-IUS and 12.2 g/dL and 19.0 mcg/L with oral MPA, respectively. At Cycle 6, the corresponding medians were 13.4 g/dL and 34.0 mcg/L with the LNG-IUS and 12.6 g/dL and 21.0 mcg/L with oral MPA. At Cycle 6, the proportion of women who rated their bleeding as 'improved' was higher with the LNG-IUS than with oral MPA, both according to investigator assessment (93.6% vs. 61.0%) and self-assessment (93.6% vs. 67.1%). CONCLUSIONS:Women treated with the LNG-IUS had greater increases in median hemoglobin and serum ferritin levels, and higher rates of subjective improvement than women treated with oral MPA.
Authors: Luis Bahamondes; Victor Marin; Silvia Ciarmatori; Agnaldo L Silva-Filho; Juan Manuel Acuña; Maria Y Makuch Journal: Obstet Gynecol Int Date: 2016-08-25