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Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Product: Phase 1 Results in Healthy Pre- and Postmenopausal Women.
Clin Pharmacol Drug Dev
June 2024
Clinical Pharmacology, AbbVie Inc., North Chicago, IL, USA.
Fixed-dose combination (FDC) therapies can enhance patient convenience and adherence to prescribed treatment regimens. Elagolix is a novel oral gonadotropin-releasing hormone receptor antagonist approved for management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. Hormonal add-back therapy can attenuate the reversible hypoestrogenic effects of elagolix.
View Article and Find Full Text PDFEffects of norethindrone on the growth, behavior, and thyroid endocrine system of adult female western mosquitofish (Gambusia affinis).
Ecotoxicol Environ Saf
November 2023
Faculty of Chemistry and Environmental Science, Guangdong Ocean University, Zhanjiang 524088, China. Electronic address:
Progestins are mainly used in pharmacotherapy and animal husbandry and have received increasing attention as they are widely detected in various aquatic ecosystems. In this study, adult female western mosquitofish (Gambusia affinis) were exposed to different concentrations of norethindrone (NET) (solvent control, 5.0 (L), 50.
View Article and Find Full Text PDFDrug-Drug Interaction Potential of Mavacamten with Oral Contraceptives: Results from a Clinical Pharmacokinetic Study and a Physiologically Based Pharmacokinetic Model.
J Clin Pharmacol
November 2023
Bristol Myers Squibb, Princeton, NJ, USA.
Mavacamten is a potential inducer of cytochrome P450 (CYP) 3A4 and, as such, could reduce the exposure of the active components of oral contraceptives, ethinyl estradiol (EE) and norethindrone (NOR), where CYP3A4 is involved in metabolism. This study assessed if repeat doses of mavacamten led to a drug-drug interaction with EE and/or NOR. This was an open-label study in healthy women.
View Article and Find Full Text PDFDevelopment and validation of a multiplexed assay for the measurement of long-acting hormonal contraceptives in plasma via liquid chromatography-tandem mass spectrometry.
J Pharm Biomed Anal
May 2023
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address:
Background: Exogenous progestins are an effective tool for hormonal contraception and family planning. Progestins may be delivered as oral pills, intramuscular or subcutaneous injections, vaginal rings, or intrauterine devices. Drug concentrations may vary based on the route and duration of delivery.
View Article and Find Full Text PDFA combined injectable contraceptive improves plasma redox status and does not induce vascular changes in female rats.
An Acad Bras Cienc
August 2021
Grupo de Pesquisa em Farmacologia de Produtos Bioativos, Universidade Federal do Rio de Janeiro, Campus Macaé Professor Aloísio Teixeira, Rua Aloísio da Silva Gomes, 50, Granja dos Cavaleiros, 27930-560 Macaé, RJ, Brazil.
This study aimed to investigate the effects of the combined injectable contraceptive (CIC) containing estradiol valerate (EV) and norethisterone enanthate (NET-EN) on aorta function and morphology, as well as on redox status, of female Wistar rats. Female rats (9-10 weeks of age) received intramuscular injections of CIC (0.1 mg EV plus 1 mg NET-EN) or castor oil (control group, CTL) for 8 weeks, once a week.
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