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Levonorgestrel (LNG) 90 μg/ethinyl estradiol (EE) 20 μg was shown to have a good endometrial safety profile after a substudy of a phase 3, open-label, 1- year trial that was conducted at 92 sites in the United States and Canada. Healthy, sexually active women, aged 18 to 49 years, took 1 pill of LNG 90 μg/EE 20 μg daily for 12 months. The 93 participants in the histology portion of the study had an endometrial biopsy at the pretreatment visit and during the last month. The results of the biopsies showed no inconsistent changes in the endometria, and there were no findings of hyperplasia or malignancy.
Ms. Farley is a freelance medical writer based in Wakefield, RI.