Nomegestrol Acetate/Estradiol
- 1 October 2012
- journal article
- Published by Springer Science and Business Media LLC in Drugs
- Vol. 72 (14), 1917-1928
- https://doi.org/10.2165/11208180-000000000-00000
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.Keywords
This publication has 29 references indexed in Scilit:
- Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β‐estradiol in comparison to levonorgestrel/ethinylestradiolActa Obstetricia et Gynecologica Scandinavica, 2012
- 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 regimenThe European Journal of Contraception & Reproductive Health Care, 2011
- Metabolic effects of contraceptive steroidsReviews in Endocrine and Metabolic Disorders, 2011
- Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17β-estradiol, compared with those of levonorgestrel/ethinyl estradiolThrombosis and Haemostasis, 2011
- The use of newer progestins for contraceptionContraception, 2010
- After 50 years of ethinylestradiol, another oestrogen in combined oral contraceptivesThe European Journal of Contraception & Reproductive Health Care, 2010
- Mechanisms of thrombosis related to hormone therapyThrombosis Research, 2009
- Estradiol Valerate/DienogestDrugs, 2009
- Drospirenone/Ethinylestradiol 3mg/20??g (24/4 Day Regimen)Drugs, 2007
- Effect of Nomegestrol acetate on spinability, ferning and mesh dimension of midcycle cervical mucusContraception, 1991