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

BMJ. 1998 Apr 11;316(7138):1122-6. doi: 10.1136/bmj.316.7138.1122.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Drug Administration Routes
  • Female
  • Follow-Up Studies
  • Humans
  • Hysterectomy*
  • Levonorgestrel / administration & dosage*
  • Middle Aged
  • Progesterone Congeners / administration & dosage*
  • Quality of Life
  • Treatment Outcome
  • Uterine Hemorrhage / drug therapy*
  • Uterine Hemorrhage / surgery

Substances

  • Progesterone Congeners
  • Levonorgestrel