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Prevention of tamoxifen induced endometrial polyps using a levonorgestrel releasing intrauterine system: Long-term follow-up of a randomised control trial
Gynecologic Oncology, 08/06/09
Gardner FJE et al. - In a trial to test the hypothesis that a levonorgestrel intrauterine system (LNG-IUS) can prevent the pro-proliferative uterine responses of tamoxifen for up to 4.5 yrs, it was verified that LNG-IUS induces benign endometrial changes and prevents endometrial polyps but only during its use in women taking tamoxifen. Endometrial thickness is a risk factor for development of polyps.
Methods- A randomised-controlled trial of postmenopausal women who had taken at least 1 year of adjuvant tamoxifen therapy.
- 122 women were recruited; 9 were found to be ineligible after randomisation.
- Average duration of follow-up was 26.25 mos in the surveillance group and 24.2 mos in the LNG-IUS group.
- Women with LNG-IUS in situ at the time of final assessment had decidualised endometrium, and no polyps.
- In the surveillance group, new polyps arose in 8 cases.
- There were 3 new polyps in the group initially randomised to LNG-IUS, 1 in a pt who did not have the device inserted, and 2 occurred in pts following the removal of the LNG-IUS.
- Univariate Cox proportional hazards regression models identified only endometrial thickness at trial entry as a statistically significant variable for the development of polyps.
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