Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen

Abstract

ObjectivesThe primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE).MethodsWomen (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n = 1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n = 535) for 13 cycles.ResultsEstimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged ≤ 35 years and 0.31 and 0.66 for all women (18–50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs.ConclusionsThese data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.

Combined hormonal contraceptives: prescribing patterns, compliance, and benefits versus risks

“…Data shows that a 24/4 regimen yields a more enhanced ovarian suppression with less follicular growth and consequently a slight but significantly higher efficacy [Dinger et al 2011]. Moreover, the 24/4 regimen seems do reduce menstrual blood loss [Mansour et al 2011;Christin-Maitre et al 2011] and to diminish cycle-related symptoms such as headache, bloating and breast tenderness [Sulak et al 2000].…”

“…Consequently, there are now at least two different COCs available with estradiol as the estrogen component. These formulations minimize the risk of break-through bleeding but the bleeding pattern differs from the EE pill as a substantial number of users will be amenorrhoic [Mansour et al 2011;Fraser et al 2011].…”

How to reduce the number of side effects produced by COCs and improve adherence: simple tips for practitioners

“…Так, указанный в литературе индекс Перля для E2/НМГА составил 0,38 у женщин в возрасте младше 35 лет и 0,31 в смешанной группе (18-50 лет) среди 1 057 женщин, принявших участие в исследовании [14]. Что касается клинической эффективности E2В/ ДНГ, обширное много-центровое исследование оценило в совокупности 1 377 женщин в возрасте от 18 до 50 лет более чем в 20 циклах.…”

“…Однако частота отказов от приема E2/НМГА была выше, чем при приеме E2В/ДНГ, и составила 17,3 против 10,2% соответственно (по срав-нению с ЭЭ/ДРСП -10,4%) [14,16,17].…”

Efficacy and side‐effects of oral contraceptives

“…2 Clinical trial data for both Qlaira and Zoely suggest that absent withdrawal bleeds are not uncommon, which may not be acceptable to some women. 3,4 Mode of action Contraceptive efficacy is maintained by several mechanisms. The principal mode of action is to suppress folliculogenesis, inhibiting ovulation.…”