Endometrial histology following 1 year of a continuous daily regimen of levonorgestrel 90 micro g/ethinyl estradiol 20 micro g
Department of Obstetrics and Gynecology
Medical Subject Headings
Adolescent; Adult; Contraceptive Agents, Female; Endometrium; Estrogens; Ethinyl Estradiol; Female; Humans; Levonorgestrel; Metrorrhagia; Middle Aged; Safety; Treatment Outcome
Obstetrics and Gynecology
OBJECTIVE: The objective of this study was to evaluate the effect of a continuous daily regimen of levonorgestrel (LNG) 90 micro g/ethinyl estradiol (EE) 20 micro g on endometrial histology.
METHODS: This was a substudy of a large phase 3 trial conducted in six sites in North America. Healthy and sexually active women aged between 18 and 49 years took LNG 90 micro g/EE 20 micro g daily for 1 year. Results from endometrial biopsies performed at pretreatment baseline and those after at least 6 months of treatment were compared. RESULTS: Of the 146 participants, 93 had a baseline biopsy and completed at least six pill packs. Before treatment, 56 subjects (60%) had an endometrial biopsy with findings classified as "weakly proliferative or proliferative." During the last on-therapy visit, 48 subjects (52%) had an endometrium categorized as "other," which included primarily an inactive or benign endometrium (n=42). No hyperplasia or malignancy was observed during the study.
CONCLUSION: The results of a 1-year continuous regimen of LNG 90 micro g/EE 20 micro g were shown to have a good endometrial safety profile.
Johnson, Julia V.; Grubb, Gary S.; and Constantine, Ginger D., "Endometrial histology following 1 year of a continuous daily regimen of levonorgestrel 90 micro g/ethinyl estradiol 20 micro g" (2007). Obstetrics and Gynecology Publications and Presentations. 65.