J Gynecol Oncol.  2013 Apr;24(2):128-134. 10.3802/jgo.2013.24.2.128.

LNG-IUS treatment of non-atypical endometrial hyperplasia in perimenopausal women: a randomized controlled trial

Affiliations
  • 1Department of Obstetrics and Gynecology, Mansoura University, Faculty of Medicine, Mansoura, Egypt. hatem_ah@hotmail.com
  • 2Department of Clinical Pharmacology, Mansoura University, Faculty of Medicine, Mansoura, Egypt.
  • 3Department of Diagnostic Radiology, Mansoura University, Faculty of Medicine, Mansoura, Egypt.

Abstract


OBJECTIVE
To compare the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) and oral norethisterone acetate (NET) for treatment of non-atypical endometrial hyperplasia in perimenopausal women.
METHODS
One hundred and twenty perimenopausal women with non-atypical endometrial hyperplasia were selected in this randomized controlled trial. Patients received LNG-IUS (n=59) or NET (n=61; 15 mg/day for 3 weeks/cycle) for 3-6 months. Outpatient follow-up with endometrial biopsies were undertaken at 3, 6, and 12 months intervals after treatment. Outcome measures were; the regression rate, the time to regression and hysterectomy rate.
RESULTS
A significantly higher regression rate was noted in the LNG-IUS group than in NET group at the 3rd, 6th and 12th month follow-up visits using intention-to-treat analysis (67.8% vs. 47.5%, relative risk [RR], 1.42; 79.7% vs. 60.7%, RR, 1.31; and 88.1% vs. 55.7%, RR, 1.58, respectively). However, no significant difference was found regarding the median time to regression (3 months). The hysterectomy rate during the follow-up period was significantly higher in the NET group (57.4% vs.22%, p<0.001).
CONCLUSION
LNG-IUS treatment of non-atypical endometrial hyperplasia in perimenopausal women is more effective than NET for achieving disease regression for the majority within 1 year. Moreover, it can reduce the number of hysterectomies performed.

Keyword

Abnormal uterine bleeding; Endometrial hyperplasia; Levonorgestrel-releasing intrauterine system; Non-atypical; Norethisterone acetate

MeSH Terms

Biopsy
Endometrial Hyperplasia
Female
Follow-Up Studies
Humans
Hysterectomy
Norethindrone
Outcome Assessment (Health Care)
Outpatients
Norethindrone

Figure

  • Fig. 1 CONSORT flow chart of participants in this trial. ITT, intention-to-treat analysis; LNG-IUS, levonorgestrel-releasing intrauterine system; NET, norethisterone acetate; PPA, per protocol analysis.


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