Contraceptive efficacy and tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study

Abstract

BackgroundThe contraceptive efficacy and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg to extend the menstrual cycle and enable management of intracyclic (breakthrough) bleeding (flexibleMIB) was investigated and the bleeding pattern compared with a conventional 28-day regimen and a fixed extended 124-day regimen.Study designThis Phase III, 2-year, multicentre, open-label study randomly (4:1:1) allocated women (aged 18–35 years) to the following regimens: flexibleMIB (24–120 days' active hormonal intake with 4-day tablet-free intervals); conventional (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). Primary outcomes included the number of bleeding/spotting days during Year 1 (all regimens) and the number of observed unintended pregnancies over 2 years (flexibleMIB only).ResultsResults were analysed in 1067 women (full analysis set). The mean number of bleeding/spotting days was lower with the flexibleMIB vs the conventional regimen [41.0±29.1 (95% CI 38.8–43.3) vs 65.8±27.0 (95% CI 62.2–69.4) days, p<0.0001; treatment difference −24.8 (95% CI −29.2 to −20.3) days]. The corresponding value for the fixed extended regimen was 60.9±51.1 (95% CI 53.9–67.9) days. The Pearl Index for the flexibleMIB regimen was 0.64 (95% CI 0.28–1.26). All regimens had comparable tolerability profiles.ConclusionsEE 20 μg/DRSP 3 mg administered as a flexible extended regimen with MIB is effective, well tolerated and is associated with statistically significantly fewer bleeding/spotting days and fewer withdrawal bleeding episodes vs EE/DRSP in a conventional 28-day regimen. The flexibleMIB also provided statistically significantly fewer spotting days vs EE/DRSP in a fixed extended 124-day regimen (post hoc evaluation). The flexibleMIB regimen allows women to extend their menstrual cycle and manage their intracyclic (breakthrough) bleeding.

The influence of extended regimen of hormone contraception in comparison with conventional regimen on carbohydrates metabolism and bleeding pattern in fertile women with diabetes mellitus type 1 (a pilot study)

“…Наши данные согласуются с результатами круп-ного многоцентрового рандомизированного иссле-дования, проведенного C. Klipping и соавт. [14]. В течение первых 90 дней исследования среднее коли-чество дней кровотечений/мажущих выделений в группе стандартного режима дозирования оказалось 22,6, в группе пролонгированного режима -21,7, при этом мажущие выделения продолжались 8 и 12,7 дня, а кровотечения 14,6 и 9 дней соответственно.…”

“…С учетом данных, полу-ченных C. Klipping и соавт. [14], пролонгирование исследования наиболее вероятно привело бы к зна-чимому снижению общего количества дней кровоте-чений/мажущих выделений в группе пролонгиро-ванной терапии, а также к постепенному уменьше-нию длительности «внеплановых» мажущих выделе-ний и кровотечений. Также следует учитывать не-большой размер выборки в нашем исследовании (по 30 больных в каждой группе), его пилотный харак-тер, что может приводить к уменьшению мощности исследования и точности получаемых результатов.…”

“…Для сравнения укажем, что в исследование C. Klipping и соавт. [14] были рандомизированы 1166 здоровых пациенток в 37 клинических центрах Гер-мании, Канады и Нидерландов, а продолжитель-ность исследования составила 2 года.…”

Women&rsquo;s perceptions about reducing the frequency of monthly bleeding: results from a multinational survey

“…In this regard, the efficacy and tolerability of a combined OC in a flexible extended regimen has recently been investigated which, when compared with the conventional 28-day regimen, showed significant reductions in the number of bleeding/spotting days and withdrawal bleeding episodes. 21,22 Previous studies have shown that some women worry about the possibility of menstrual "build-up," creation of an "unnatural" state, and the possibility of pregnancy with "missed" monthly bleeding. [6][7][8]20 These misconceptions were also observed in the present survey, in which most women cited health concerns as the main reason for not reducing bleeding frequency, either occasionally or regularly; a large proportion of women also reported that they felt that monthly bleeding was necessary to cleanse the body.…”

Flexible extended regimen of the micro-dose COC: the optimization of contraceptive, therapeutic and prophylactic effectiveness

“…Новый режим приема КОК оказался прост для понимания, большинство жен-щин были довольны данной схемой [19][20][21][22][23].…”