Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia

Abstract

Objective: To compare the efficacy and acceptability of the levonorgestrel intrauterine system and norethisterone for the treatment of idiopathic menorrhagia.

Design: A randomised comparative parallel group study.

Setting: Gynaecology outpatient clinic in a teaching hospital.

Participants: Forty-four women with heavy regular periods and a measured menstrual blood loss exceeding 80 ml.

Methods: Twenty-two women had a levonorgestrel intrauterine system inserted within the first seven days of menses, and 22 women received norethisterone (5 mg three times daily) from day 5 to day 26 of the cycle for three cycles.

Main outcome measures: The main outcome measure was the change in objectively assessed menstrual blood loss after three months of treatment.

Results: When menstrual blood loss at three months was expressed as a percentage of the control, the levonorgestrel intrauterine system reduced menstrual blood loss by 94% (median reduction 103 ml; range 70 to 733 ml), and oral norethisterone by 87% (median reduction 95 ml; range 56 to 212 ml). After three cycles of treatment 76% of the women in the levonorgestrel intrauterine system group wished to continue with the treatment, compared with only 22% of the norethisterone group.

Conclusions: Both the levonorgestrel intrauterine system and oral norethisterone in this regimen provided an effective treatment for menorrhagia in terms of reducing menstrual blood loss to within normal limits. The levonorgestrel intrauterine system was associated with higher rates of satisfaction and continuation with treatment, and thus offers an effective alternative to currently available medical and surgical treatments for menorrhagia.

PIP: The efficacy and acceptability of two new approaches to the treatment of idiopathic menorrhagia--the levonorgestrel intrauterine system and norethisterone--were compared in 45 women recruited from a gynecology outpatient clinic at a UK teaching hospital. All study participants had heavy regular periods and a measured menstrual blood loss exceeding 80 ml. 22 women were randomly assigned to have a levonorgestrel intrauterine system inserted within the first 7 days of menses and 22 women received 5 mg of norethisterone 3 times daily from day 5 to day 26 of their cycle for 3 cycles. Compared to baseline, the levonorgestrel intrauterine system reduced menstrual blood loss by 94% (median reduction, 103 ml) and oral norethisterone reduced it by 87% (median reduction, 95 ml). Recorded in both treatment groups were significant decreases in breast tenderness, mood swings, intermenstrual bleeding, and interferences in daily life caused by menstruation. After 3 treatment cycles, 64% of women in the levonorgestrel group indicated they liked the treatment "well" or "very well" and 77% elected to continue the regimen. In the norethisterone group, these rates were only 44% and 22%, respectively. Although both regimens reduced menstrual blood loss to within normal limits, the levonorgestrel intrauterine system was associated with higher satisfaction and thus offers an effective alternative to currently available medical and surgical treatments for menorrhagia.