We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Nomegestrol Acetate/Estradiol: In Oral Contraception.
- Authors
Yang, Lily P. H.; Plosker, Greg L.
- 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, natural estrogen. It is the first monophasic combine oral contraceptive to contain estradiol, and is taken in 28-day cycles, consisting of 24 active therapy days wit 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 (age 18-50 years), nomegestrol acetate/estradiol was at least as effective as drospirenone/ethinylestradiol a contraceptive therapy, as the pregnancy rates i 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 dose 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 wit that expected for a combined oral contraceptive. The most commonly reported adverse events were acne an 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 period.
- Subjects
CLINICAL trials; DRUG interactions; ORAL contraceptives; HEALTH outcome assessment; SAFETY; TREATMENT effectiveness; PHARMACODYNAMICS
- Publication
Drugs, 2012, Vol 72, Issue 14, p1917
- ISSN
0012-6667
- Publication type
Journal Article
- DOI
10.2165/11208180-000000000-00000