Open randomised study of use of levonorgestrel releasing intrauterine system as alternative to hysterectomy

OBJECTIVES: To assess whether the levonorgestrel intrauterine system could provide a conservative alternative to hysterectomy in the treatment of excessive uterine bleeding. DESIGN: Open randomised multicentre study with two parallel groups: a levonorgestrel intrauterine system group and a control group. SETTING: Gynaecology departments of three hospitals in Finland. SUBJECTS: Fifty six women aged 33-49 years scheduled to undergo hysterectomy for treatment of excessive uterine bleeding. INTERVENTIONS: Women were randomised either to continue with their current medical treatment or to have a levonorgestrel intrauterine system inserted. MAIN OUTCOME MEASURE: Proportion of women cancelling their decision to undergo hysterectomy. RESULTS: At 6 months, 64.3% (95% confidence interval 44.1 to 81.4%) of the women in the levonorgestrel intrauterine system group and 14.3% (4.0 to 32.7%) in the control group had cancelled their decision to undergo hysterectomy (P < 0.001). CONCLUSIONS: The use of the levonorgestrel intrauterine system is a good conservative alternative to hysterectomy in the treatment of menorrhagia and should be considered before hysterectomy or other invasive treatments.