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Randomized Controlled Trial
. 2016 Aug;123(9):1512-9.
doi: 10.1111/1471-0528.13763. Epub 2015 Dec 2.

Relapse risk of endometrial hyperplasia after treatment with the levonorgestrel-impregnated intrauterine system or oral progestogens

A Ørbo  1   2 , M Arnes  2 , A B Vereide  3 , B Straume  4
Affiliations
Randomized Controlled Trial

Relapse risk of endometrial hyperplasia after treatment with the levonorgestrel-impregnated intrauterine system or oral progestogens

A Ørbo et al. BJOG. 2016 Aug.

Abstract

Objective: To investigate relapse rates after the successful treatment of patients with non-atypical endometrial hyperplasia who were randomised to either a levonorgestrel-impregnated intrauterine system (LNG-IUS; Mirena(®) ) or two regimens of oral medroxyprogesterone acetate (MPA) after primary histological response.

Design: A multicentre randomised trial.

Setting: Ten different outpatient clinics localised in hospitals and seven gynaecological private practices in Norway.

Population: One hundred and fifty-three women aged 30-70 years with low- or medium-risk endometrial hyperplasia met the inclusion criteria, and 153 completed the therapy.

Methods: Patients were randomly assigned to one of the following three treatment arms: LNG-IUS; 10 mg of oral MPA administered for 10 days per cycle for 6 months; or 10 mg of oral MPA administered daily for 6 months. The women were followed for 24 months after ending therapy.

Main outcome measures: Histological relapse of endometrial hyperplasia.

Results: Histological relapse was observed in 55/135 (41%) women who had an initial complete treatment response. The relapse rates were similar in the three therapy groups (P = 0.66). In the multivariable analyses relapse was dependent on menopausal status (P = 0.0005) and estrogen level (P = 0.0007).

Conclusions: The risk of histological relapse of non-atypical endometrial hyperplasia is high within 24 months of ceasing therapy with either the LNG-IUS or oral MPA. Continued endometrial surveillance and prolonging progestogen therapy should be considered.

Tweetable abstract: Relapse of endometrial hyperplasia after successful treatment is independent of therapy regime.

Keywords: Endometrial hyperplasia; levonorgestrel-impregnated intrauterine system; medroxyprogesterone acetate relapse of endometrial hyperplasia; recurrence of endometrial hyperplasia.

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Figures

Figure 1
Figure 1
Flow chart showing the enrolment, allocation, results of the initial therapy, and relapses during the 24‐month follow‐up period.
Figure 2
Figure 2
Kaplan–Meier curve for relapse of hyperplasia during 24 months in women with initial regression treated with either the LNG‐IUS or oral progestogen.
See this image and copyright information in PMC

Comment in

References

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