An open label, comparative study of the effects of a dose-reduced oral contraceptive containing 20 microg ethinyl estradiol and 100 microg levonorgestrel on hemostatic, lipids, and carbohydrate metabolism variables

Contraception
Jan EndrikatB Düsterberg

Abstract

In this open label, randomized study we compared the influence of a dose-reduced oral contraceptive containing 20 microg ethinyl estradiol (EE) and 100 microg levonorgestrel (20 EE) with a reference preparation containing 30 microg EE and 150 microg levonorgestrel (30 EE) on hemostatic, lipids, and carbohydrate metabolism variables. Data from 48 volunteers were obtained. The direction of the change (increase or decrease) in most of the hemostatic variables were similar in both treatment groups. In particular, prothrombin fragment 1 + 2 increased during treatment, reaching a median percent change of 40% in the 20 EE group and of 17% in the 30 EE group after one year. D-Dimer fibrin split products remained virtually unchanged, with no change at Cycle 13. The median HDL2 cholesterol levels decreased by 26% in the 20 EE group and by 39.8% in 30 EE group (p = 0.0045 for group difference) after one year. The median one year change for LDL cholesterol was 3.23% in the 20 EE group, compared to 25% in the 30 EE group, for VLDL 11.1% compared to 38.8%, respectively, and for total triglycerides 10.0% compared to 37.5%, respectively. The median absolute change for the area under the curve (AUC)(0-3h) for glucose at treatment Cycle 13 was 4...Continue Reading

References

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Citations

May 4, 2011·Reviews in Endocrine & Metabolic Disorders·Regine Sitruk-Ware, Anita Nath
Dec 6, 2014·International Journal of Endocrinology·Stefano Lello, Andrea Cavani
Mar 23, 2011·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Mandana RadJacobus Burggraaf
Nov 10, 2011·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Ulla M ÅgrenEllen Mommers
May 14, 2011·Endocrinology and Metabolism Clinics of North America·Angela Boldo, William B White
Dec 2, 2008·Contraception·Patrícia Margareth LizarelliMaristela Carbol Patta
Jan 10, 2004·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Gurkan KiranHasan C Ekerbicer
May 27, 2015·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Iñaki LeteAxelle Pintiaux
Jan 17, 2009·Journal of the American College of Cardiology·Chrisandra L Shufelt, C Noel Bairey Merz
May 18, 2016·Expert Opinion on Drug Metabolism & Toxicology·Giovanni GrandiAngelo Cagnacci
Dec 5, 2002·Pharmacoepidemiology and Drug Safety
Mar 23, 2017·The Journal of Clinical Endocrinology and Metabolism·Jeffrey T JensenRandy L Bogan
Jul 1, 2009·Current Cardiology Reports·Candice K SilversidesSamuel C Siu
May 3, 2014·The Cochrane Database of Systematic Reviews·Laureen M LopezKenneth F Schulz
Jul 18, 2017·Expert Review of Clinical Pharmacology·Manuela FarrisGiuseppe Benagiano
Nov 12, 2019·The Cochrane Database of Systematic Reviews·Laureen M LopezKenneth F Schulz
Aug 18, 2020·American Journal of Epidemiology·Cherry Yin-Yi ChangPei-Chun Chen

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