Levonorgestrel-impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial.

Abstract

OBJECTIVE:

The purpose of this study was to investigate if the levonorgestrel-impregnated intrauterine device (LNG-IUS, Mirena(®) ) is safe and effective as therapy for low-risk and medium-risk endometrial hyperplasia compared with oral medroxyprogesterone (MPA).

DESIGN:

A multicentre randomised trial.

SETTING:

Norway.

POPULATION:

In all, 170 women aged 30-70 years with low- or medium-risk endometrial hyperplasia who met inclusion criteria.

METHODS:

Patients were randomly assigned to one of three treatment arms: LNG-IUS; oral MPA 10 mg administered for 10 days per cycle, or continuous oral MPA 10 mg daily, for 6 months.

MAIN OUTCOME MEASURES:

The primary outcome measure was normalisation or persisting hyperplasia.

RESULTS:

After 6 months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not (P < 0.001). Responses were obtained for all the women in the LNG-IUS group (53/53, 95% CI 0.93-1.0) and for 96% of the women in the continuous oral group (46/48, 95% CI 0.86-0.99). Only 69% of the women in the cyclic oral group were responders (36/52, 95% CI 0.55-0.81). Adverse effects were relatively common with minimal differences between therapy groups.

CONCLUSION:

In the first trial of its kind, women treated with the LNG-IUS showed histologically normal endometrium after 6 months of therapy for endometrial hyperplasia. Cyclical progestogens are found to be less effective compared with continuous oral therapy and LNG-IUS and should not be used for this purpose.

• Authors: A Orbo, Ab Vereide, M Arnes, I Pettersen, B Straume
• Journal: BJOG : an international journal of obstetrics and gynaecology (BJOG) Vol. 121 Issue 4 Pg. 477-86 (Mar 2014) ISSN: 1471-0528 [Electronic] England
• PMID: 24286192 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Chemical References

• Contraceptives, Oral, Synthetic
• Progestins
• Levonorgestrel
• Medroxyprogesterone

Topics

• Administration, Oral
• Adult
• Aged
• Contraceptives, Oral, Synthetic (therapeutic use)
• Drug Administration Schedule
• Endometrial Hyperplasia (drug therapy)
• Female
• Follow-Up Studies
• Humans
• Intrauterine Devices, Medicated
• Levonorgestrel (therapeutic use)
• Medroxyprogesterone (therapeutic use)
• Middle Aged
• Norway
• Progestins (therapeutic use)
• Risk
• Single-Blind Method
• Treatment Outcome