Absence of Drug-Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial

Journal of Clinical Pharmacology
Rüdiger NaveHeinz Schmitz

Abstract

Intravaginal rings (IVRs) are an established option for continuous administration of drugs in women. The combination of anastrozole (ATZ) and levonorgestrel (LNG) in an IVR with an intended 4-week wearing period has been considered for long-term treatment of endometriosis-associated pelvic pain. A randomized, parallel-group, multicenter phase 2b study to assess the efficacy and safety of different dose combinations in women with symptomatic endometriosis has recently been performed. This paper will focus on the investigation of pharmacokinetic (PK) effects of ATZ on LNG using data collected from this study. Two hundred sixteen patients were randomized to the treatment group with IVRs releasing LNG 40 μg/day alone or in combination with ATZ 300 μg/day, 600 μg/day, or 1050 μg/day for 12 weeks. PK blood samples were taken before dosing and before IVR replacement or removal (days 28, 56, and 84). The primary PK parameter was the plasma concentration in apparent steady state of ATZ and LNG at the end of each IVR wearing period. Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 μg/L at 300, 600, and 1050 μg/day nominal release, res...Continue Reading

References

Oct 1, 1976·Annals of Internal Medicine·A S BayerL B Guze
Apr 2, 1998·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·G M Higa, N alKhouri
Jun 28, 2005·Human Reproduction·Stephen KennedyUNKNOWN ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group
Apr 22, 2006·Contraception·Maria Margarete HidalgoLuis Bahamondes
Jan 30, 2007·Clinical Pharmacology and Therapeutics·S-M HuangL J Lesko
Jan 18, 2014·Human Reproduction·G A J DunselmanUNKNOWN European Society of Human Reproduction and Embryology

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BETA
contraception

Clinical Trials Mentioned

NCT02203331

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