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A randomized clinical trial of a levonorgestrel‐releasing intrauterine system and a low‐dose combined oral contraceptive for fibroid‐related menorrhagia
Author(s) -
Sayed Gamal H.,
Zakherah Mahmoud S.,
ElNashar Sherif A.,
Shaaban Mamdouh M.
Publication year - 2011
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.2010.08.009
Subject(s) - medicine , levonorgestrel , randomized controlled trial , gynecology , anemia , ethinylestradiol , hazard ratio , population , obstetrics , family planning , confidence interval , research methodology , environmental health
Objective To compare the efficacy of a levonorgestrel‐releasing intrauterine system (LNG‐IUS) with that of a low‐dose combined oral contraceptive (COC) in reducing fibroid‐related menorrhagia. Methods In this single‐center, open, randomized clinical trial, 58 women with menorrhagia who desired contraception were randomized to receive a LNG‐IUS or COC. The outcomes included treatment failure, defined as the need for another treatment; menstrual blood loss (MBL) by the alkaline hematin method and a pictorial assessment chart (PBAC); hemoglobin levels; and “lost days.” Results Treatment failed in 6 women (23.1%) in the LNG‐IUS group and 11 (37.9%) in the COC group, for a hazard ratio of 0.46 (95% CI, 0.17–1.17, P = 0.101). Using the alkaline hematin test, the reduction of MBL was significantly greater in the LNG‐IUS group (90.9% ± 12.8% vs 13.4% ± 11.1%; P < 0.001). Using PBAC scores, the reduction was also significantly greater in the LNG‐IUS group (88.0% ± 16.5% vs 53.5% ± 51.2%; P = 0.02). Moreover, hemoglobin levels increased from 9.7 ± 1.9 g/dL to 11.7 ± 1.2 g/dL ( P < 0.001) and lost days decreased from 8.2 ± 3.3 days to 1.3 ± 1.5 days ( P = 0.003) in the LNG‐IUS group. Conclusion Although the rate of treatment failure was similar in both groups, the LNG‐IUS was more effective in reducing MBL than the COC in women with fibroid‐related menorrhagia.