title: Nomegestrol acetate/estradiol: in oral contraception.
abstract: Nomegestrol acetate/estradiol is a combined oral contraceptive with approval in many countries. This fixed-dose combination tablet contains nomegestrol acetate, a highly selective progestogen, and estradiol, a natural estrogen. It is the first monophasic combined oral contraceptive to contain estradiol, and is taken in 28-day cycles, consisting of 24 active therapy days with 4 placebo days (i.e. 24/4-day cycles). In two large, 1-year, randomized, open-label, multicentre, phase III trials in healthy adult women (aged 18-50 years), nomegestrol acetate/estradiol was at least as effective as drospirenone/ethinylestradiol as contraceptive therapy, as the pregnancy rates in women aged 18-35 years (primary efficacy population) in terms of the Pearl Index (primary endpoint) were numerically lower with nomegestrol acetate/estradiol, although the between-group difference was not statistically significant. In both trials, nomegestrol acetate/estradiol was given in a 24/4-day cycle, and drospirenone/ethinylestradiol was given in a 21/7-day cycle. The criteria for using condoms in case of forgotten doses were less stringent in the nomegestrol acetate/estradiol group than in the drospirenone/ethinylestradiol group. Nomegestrol acetate/estradiol therapy for up to 1 year was generally well tolerated in healthy adult women, with an acceptable tolerability profile in line with that expected for a combined oral contraceptive. The most commonly reported adverse events were acne and abnormal withdrawal bleeding (most often shorter, lighter or absent periods). Overall, compared with drospirenone/ethinylestradiol, nomegestrol acetate/estradiol appeared to be associated with less favourable acne-related outcomes, and shorter, lighter or absent periods.
authors.affiliation: Adis, Auckland, New Zealand. demail@springer.com
authors.forename: Lily P H
authors.initials: LP
authors.lastname: Yang
authors.forename: Greg L
authors.initials: GL
authors.lastname: Plosker
mesh_terms: D000152:Acne Vulgaris / Q000139:chemically induced; D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008535:Megestrol / Q000008:administration & dosage* / Q000819:agonists / Q000737:chemistry; D008597:Menstrual Cycle / Q000187:drug effects*; D008875:Middle Aged; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000819:agonists / Q000737:chemistry; D011247:Pregnancy; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D016032:Randomized Controlled Trials as Topic; D055815:Young Adult
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004967:Estrogens; D009649:Norpregnadienes; D045167:Progesterone Congeners; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol; D004958:Estradiol; C038501:nomegestrol acetate; D008535:Megestrol