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Nomegestrol acetate/estradiol: in oral contraception.
Drugs. 2012 Oct 01; 72(14):1917-28.D

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+Show Affiliations

Adis, Auckland, New Zealand. demail@springer.comNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22950535

Citation

Yang, Lily P H., and Greg L. Plosker. "Nomegestrol Acetate/estradiol: in Oral Contraception." Drugs, vol. 72, no. 14, 2012, pp. 1917-28.
Yang LP, Plosker GL. Nomegestrol acetate/estradiol: in oral contraception. Drugs. 2012;72(14):1917-28.
Yang, L. P., & Plosker, G. L. (2012). Nomegestrol acetate/estradiol: in oral contraception. Drugs, 72(14), 1917-28. https://doi.org/10.2165/11208180-000000000-00000
Yang LP, Plosker GL. Nomegestrol Acetate/estradiol: in Oral Contraception. Drugs. 2012 Oct 1;72(14):1917-28. PubMed PMID: 22950535.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nomegestrol acetate/estradiol: in oral contraception. AU - Yang,Lily P H, AU - Plosker,Greg L, PY - 2012/9/7/entrez PY - 2012/9/7/pubmed PY - 2012/12/19/medline SP - 1917 EP - 28 JF - Drugs JO - Drugs VL - 72 IS - 14 N2 - 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. SN - 1179-1950 UR - https://www.unboundmedicine.com/medline/citation/22950535/Nomegestrol_acetate/estradiol:_in_oral_contraception_ L2 - https://dx.doi.org/10.2165/11208180-000000000-00000 DB - PRIME DP - Unbound Medicine ER -