Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Abstract

Background:The purpose of this study was to investigate the endometrial safety of an oral contraceptive containing estradiol valerate/dienogest (E2V/DNG) administered as an estrogen step-down and progestogen step-up regimen in women of reproductive age (18–50 years), using histological assessment of endometrial biopsy samples.Methods:Endometrial biopsies were taken in a subset of healthy women who took part in a multicenter, open-label, noncomparative study assessing the contraceptive efficacy and safety of an E2V/DNG oral contraceptive. In each 28-day cycle, women received E2V 3 mg on days 1–2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 1 mg on days 25–26, and placebo on days 27–28. Women underwent endometrial biopsy between days 12 and 19 of the cycle, both at screening and at cycle 20 (or at the final examination).Results:Of the 283 women who underwent an endometrial biopsy at screening, 218 underwent a follow-up biopsy at cycle 20. At screening, abnormal biopsy results, both classified as “simple hyperplasia without atypia”, were seen in two women, who were withdrawn from the trial. At cycle 20, there were no abnormal findings of endometrial hyperplasia or malignancy, and 80.9% of women had atrophic, inactive, or secretory endometrium.Conclusion:After 20 cycles of treatment, an oral contraceptive containing E2V and DNG is safe and effective to transform the endometrium into a secretory/inactive or atrophic status, and exhibits no deleterious effects on endometrial histology in women aged 18–50 years.

Hemostatic Effects of a Novel Estradiol-Based Oral Contraceptive

“…Absolute level at cycle three, intra-individual absolute change and intra-individual change from baseline to cycle three in pro-and anti-coagulatory markers in women metabolic effects of estradiol valerate/dienogest with a triphasic regimen of ethinylestradiol/ levonorgestrel. [35] In the comparative study with triphasic ethinylestradiol/levonorgestrel, levels of factors associated with activation of coagulation increased slightly with both study preparations, but generally remained well within the normal reference range. Observed changes were consistently less pronounced with estradiol valerate/dienogest relative to ethinylestradiol/levonorgestrel.…”

“…Despite the fact that levels of SHBG increased in the estradiol valerate/dienogest group, mean levels remained within the normal range, whereas in the ethinylestradiol/levonorgestrel group, the mean levels of SHBG increased to exceed the normal range. [35] It is, however, questionable whether measuring SHBG levels is the most appropriate way of assessing estrogen-induced effects of COCs. SHBG levels increase with use of COCs, with the observed net effect resulting from effects exerted by both components.…”

Qlaira<SUP>®</SUP>: a 'natural' change of direction

“…14 Efficacy data A large, multicentre, open-label European study recruited 1377 women aged between 18 and 50 years and followed them for 20 cycles. 15 The corrected Pearl index for all those entering the study was 0.34, with Qlaira being equally effective in the over-and under-35s (corrected Pearl index of 0.4). 15 A further study comparing Qlaira with a 21/7 20 µg EE/100 µg LNG pill (Miranova ® -not available in the UK) resulted in just one method failure (in the Miranova group).…”

“…15 The corrected Pearl index for all those entering the study was 0.34, with Qlaira being equally effective in the over-and under-35s (corrected Pearl index of 0.4). 15 A further study comparing Qlaira with a 21/7 20 µg EE/100 µg LNG pill (Miranova ® -not available in the UK) resulted in just one method failure (in the Miranova group). 16 These Pearl indices are similar to those reported for conventional EE-containing pills.…”

The effectiveness of contraceptive containing estradiol valerate in combination with dienogest in patients with polycystic ovary syndrome

“…Полученные результаты совпадают с мнением ряда исследователей [4] о том, что прием Э 2 В в ком-бинации с ДНГ в непрерывном режиме не оказывает отрицательного влияния на метаболические процес-сы (нормализация массы тела, углеводного и жиро-вого обмена) в организме женщины.…”