Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles

Rabe, T.; Hartschuh, Elena; Wahlström, Torsten; Höschen, Kornelia; König, Simone

doi:10.1016/j.contraception.2010.04.013

Cited by 5 publications

(4 citation statements)

References 38 publications

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“…Although the E 2 V/DNG oral contraceptive used in the current study includes four days (days 1–2 and days 25–26) of unopposed E 2 V, there was no evidence of an increase in the incidence of endometrial hyperplasia. These results support data from previous studies of combined oral contraceptives, which did not observe any changes that could be described as hyperplasic or malignant 27–30…”

Section: Discussionsupporting

confidence: 92%

“…The results of the current subgroup analysis are comparable with those of a limited number of studies that have assessed the endometrial effects of other cyclic or extended low-dose combined oral contraceptives 2,4,27–30. In a study by Anderson et al, women received a 91-day extended regimen of ethinylestradiol 30 μg/levonorgestrel 150 μg that provided low-dose estrogen (10 μg) instead of placebo during the typical seven-day hormone-free interval 27.…”

Section: Discussionsupporting

confidence: 72%

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Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Bitzer

Parke

Roemer³

et al. 2011

IJWH

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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.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 72%

Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Bitzer

Parke

Roemer³

et al. 2011

IJWH

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“…In this study, endometrial biopsies showed that the use of the flexible MIB or fixed extended regimens resulted in an inactive, atrophic or secretory endometrium in most women. These findings are similar to those reported for low-dose COCs administered in a 28-day regimen [16][17][18] or as fixed extended regimens. 19 20 Endometrial hyperplasia or malignancy was not observed in any endometrial biopsy sample in the current study, comparable to other safety profile that is comparable to other estrogen/ progestogen COCs.…”

Section: Discussionsupporting

confidence: 90%

Long-term tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study

Klipping¹,

Duijkers²,

Fortier

et al. 2012

J Fam Plann Reprod Health Care

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BackgroundThis study was designed to assess the long-term safety and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg, which allows management of intracyclic (breakthrough) bleeding [flexible management of intracyclic (breakthrough) bleeding (MIB)], in comparison to conventional 28-day and fixed extended regimens.Study designIn this Phase III, multicentre, open-label study, women (aged 18–35 years) were randomised to EE/DRSP in the following regimens: flexibleMIB (24–120 days' active hormonal intake followed by a 4-day tablet-free interval), conventional 28-day (24 days' active hormonal intake followed by a 4-day hormone-free interval) or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval) during a 1-year comparative phase. Thereafter, women entered a 1-year safety extension phase in which the majority received the flexibleMIB regimen. Safety/tolerability outcomes were measured over 2 years. A separate analysis of certain safety parameters (endometrial, hormonal, lipid, haemostatic and metabolic variables) was conducted at two of the study centres.ResultsResults were analysed in 1067 and 783 women in the comparative and safety extension phases. Overall, 56.3% of women experienced ≥1 adverse event (AE) in the safety extension phase. Serious AEs occurred in 3.0%, 1.4% and 3.3% of women receiving the flexibleMIB, conventional and fixed extended regimens, respectively. No unexpected endometrial, hormonal, lipid, haemostatic or metabolic findings occurred with any of the three regimens.ConclusionsEE/DRSP in a flexible extended regimen with management of intracyclic (breakthrough) bleeding is well-tolerated and, when administered for up to 2 years, has a good safety profile comparable to other estrogen/progestogen oral contraceptives.

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“…В ходе проведения двух постмаркетинговых наблюдательных исследований среди пациенток, которые страдали от дисменореи в последних двух циклах перед началом использования ХМА-содержащего КОК, симптомы исчезли в 66% случаев, боль при дисменорее снизилась в дальнейшем до 13% после 12 циклов использования, что впоследствии подтвердилось и российскими исследователями [24][25][26][27].…”

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Combined Hormonal Contraception and Not Only…

Ерофеева¹

2017

Medicinskij sovet

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Chlormadinone acetate-containing combined contraceptives are well researched, they have a high degree of reliability during prolonged use in different modes. They have a protective anti-atherogenic properties and is offset by the risk for cardiovascular system, because the existing data indicate that the risk of thromboembolism against the background of chlormadinone preparation is minimal to date among all COCs and is comparable with the «first-generation» progestins, like levonorgestrel. The undeniable advantage of CMA-containing COC is a neutral impact on carbohydrate metabolism and blood coagulation system. CMA COCs have anti-atherogenic effect, which makes them “the drugs of choice” in patients with sclerocystic ovaries, metabolic syndrome and systemic diseases associated with hypercoagulability.Russian scholars and Western specialists who studied the effect of CMA-containing combination drug, allow us to recommend COC Belara® to assign not only with the contraceptive purpose, but also as a product for the stability of the menstrual cycle, as the drug of choice in the hyperpolimenorrhea, al’go – and dysmenorrhea, hyperandrogenism, expressed in the form of acne, hirsutism, oily seborrhea, decrease in sexual activity because of dyspareunia, as well as to anxiolytic and sedative effect in PMS.

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Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles

Cited by 5 publications

References 38 publications

Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Endometrial safety of an oral contraceptive containing estradiol valerate and dienogest

Long-term tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study

Combined Hormonal Contraception and Not Only…

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