BACKGROUND:

abnormal uterine bleeding due to small intramural leiomyomas is a frequent indication of hysterectomy; hormone treatment may decrease the need for this surgery.

OBJECTIVE:

to evaluate if using the levonorgestreal-releasing system decreases abnormal uterine bleeding caused by small intramural leiomyomas.

MATERIALS AND METHODS:

a phase II single arm clinical trial that included women from 35 to 45 years with a diagnosis of abnormal uterine bleeding caused by small intramural leiomyomas in less than 12 cm uteri (longitudinal axis on ultrasound) and endometrial biopsy with no malignant disease; all the women had the levonorgestrel-releasing system placed. We evaluated: bleeding with the PBAC scale (Pictorial Blood Assessment Chart score), pelvic pain with the EVA scale, hematological recovery (serum hemoglobin), uterine volume (mm3) and recovery of physical and sexual activity before placement of the levonorgestrel-releasing system 3, 6 and 9 months later.

RESULTS:

20 patients were studied, 3 of these had a hysterectomy before the three month follow up period. After three months 76.4% % (IC 95%: 55.9-97) decreased bleeding more than 50% compared to baseline, after six months, all had decreased bleeding more than 50% and at nine months, nine had amenorrhea and the rest had an average reduction of 90%. Pain decreased and allowed them to recover physical and sexual activity in 90% of cases. Concentrations of hemoglobin increased an average of 0.8 g/dL and there was no clinically significant reduction of the uterine size.

CONCLUSIONS:

the levonorgestrel-releasing system significantly decreased abnormal uterine bleeding caused by small intramural leiomyomas after three months of treatment.

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