Nomegestrol acetate, sold under the brand names Lutenyl and Zoely among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. It is available both alone and in combination with estrogens for oral administration. Chemically it is 17alpha-acetoxy-6-methyl-19-norpregna-4,6-diene-3,20-dione (CAS 58652-20-3), molecular formula C22H28O4, molecular weight 348.46 g/mol. Nomegestrol acetate is a selective progestogen with high affinity for the progesterone receptor and minimal androgenic activity; it suppresses ovulation by inhibiting gonadotropin secretion, induces secretory transformation and stabilization of the endometrium, and is metabolized hepatic ally with metabolites excreted in urine and feces. Typical pharmaceutical presentations include oral tablets at therapeutic strengths of 1.5 mg to 5 mg and combined oral contraceptives containing nomegestrol acetate 2.5 mg with 17beta-estradiol 1.5 mg.
Parent: Nomegestrol Acetate
Parent: Nomegestrol Acetate
Parent: Nomegestrol Acetate
Parent: Nomegestrol Acetate
![(8R,9S,10R,13S,14S,17R)-17-Acetyl-3-ethoxy-6-formyl-13-methyl-2,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate](https://veeprho.com/wp-content/uploads/2024/10/VE0021734-8R-9S-10R-13S-14S-17R-17-Acetyl-3-ethoxy-6.png "(8R,9S,10R,13S,14S,17R)-17-Acetyl-3-ethoxy-6-formyl-13-methyl-2,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate")
Parent: Nomegestrol acetate
Quality control for nomegestrol acetate API and finished products monitors specified related substances and degradation products by validated HPLC, LC-MS or GC methods; typical specification limits used in regulatory dossiers set individual related compounds at not more than 0.10 to 0.50 percent relative to the API and total related substances at not more than 1.0 to 2.0 percent by weight depending on the impurity profile and toxicological qualification. Genotoxic and potentially mutagenic impurities are controlled to much lower thresholds consistent with ICH M7 and PDE guidance, frequently in the low microgram per day range or below 0.05 percent where applicable. Common analytical targets include positional isomers, 6-methyl and 19-nor steroidal degradation products, and oxidative metabolites; acceptance criteria and identification requirements should follow the marketing authorization or pharmacopeial monograph applicable to the region.
Nomegestrol acetate is used as an oral progestin in hormonal contraception, as a component of menopausal hormone therapy to provide progestogenic protection of the endometrium when estrogens are given, and for treating gynecological conditions such as abnormal uterine bleeding, dysmenorrhea, and other progesterone-responsive disorders according to approved indications and clinical practice.
Nomegestrol acetate acts primarily as an agonist at progesterone receptors, producing negative feedback at the hypothalamic-pituitary axis to suppress luteinizing hormone and follicle stimulating hormone secretion and thereby prevent ovulation. It also induces secretory transformation and stabilization of the endometrium, reduces endometrial proliferation caused by estrogens, and demonstrates minimal androgenic or glucocorticoid activity, contributing to its clinical tolerability profile.
