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Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia
Author(s) -
Kriplani A.,
Singh B.M.,
Lal S.,
Agarwal N.
Publication year - 2007
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2007.01.009
Subject(s) - medicine , levonorgestrel , endometrial hyperplasia , intrauterine device , hysterectomy , blood loss , gynecology , menstruation , prospective cohort study , metrorrhagia , urology , obstetrics , endometrium , population , surgery , family planning , research methodology , environmental health
Objective : To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrel‐releasing intrauterine system for menorrhagia. Methods : Sixty‐three women with menorrhagia but without uterine enlargement, endometrial hyperplasia with atypia, or endometrial carcinoma were enrolled in this prospective, open, nonrandomized clinical trial. An intrauterine system releasing 20 μg/day of levonorgestrel (LNG‐IUS; Mirena, Shering, Finland) was inserted in the postmenstrual phase. Menstrual pattern, number of bleeding days, and subjective and objective estimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years. Hemoglobin levels and endometrial thickness were evaluated at baseline and at 12 months. Treatment continuation and hysterectomy rates were noted as well as side effects. Results : The device was expelled spontaneously in 6 patients (9.52%) and removed prematurely in 9 patients (14.3%); 3 patients (4.8%) were lost to follow‐up; and 45 patients (71.4%) continued with the LNG‐IUS. Menorrhagia was cured in 35 (77.7%) of these 45 patients at 3 months and in all patients at 36 months. There was a significant decrease in the mean number of bleeding days ( P = 0.01) and PBAC score ( P = 0.00) at 1 month, and the decrease continued with treatment duration. The subjective blood loss reduction was considerable as well, and at 12 months the mean ± SD rise in hemoglobin concentration was 1.06 ± 1.7 g/dL ( P = 0.000). Endometrial thickness was decreased by 3.4 ± 3.53 mm ( P = 0.0001) at 12 months. The most common side effect was intermenstrual spotting during the first 6 months, and 18 patients (28.57%) developed amenorrhea. Conclusion : Using the LNG‐IUS is an effective and well‐accepted option overall for the medical management of menorrhagia.