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An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables.
Contraception. 2010 May; 81(5):391-400.C

Abstract

OBJECTIVE

The study was conducted to compare the effects of 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), given for 24 days each cycle, with those of 0.02 mg EE/0.15 mg desogestrel (DSG) and 0.03 mg EE/0.15 mg levonorgestrel (LNG), given for 21 days each cycle, on hemostatic, lipid, and carbohydrate metabolism parameters in healthy subjects, over six medication cycles.

STUDY DESIGN

A randomized, multicentre, open-label, Phase II trial measured markers of hemostasis, and of lipid and carbohydrate metabolism in 165 subjects randomly assigned to treatment with one of three combined oral contraceptives (COCs).

RESULTS

EE/CMA and EE/DSG had a similar effect on hemostatic parameters, the EE/LNG group showed comparatively smaller increases in the activity of factor VII [8.1% vs. 36.6% (EE/CMA) and 28.2% (EE/DSG)], protein C [5.9% vs. 32.9% (EE/CMA) and 21% (EE/DSG)] and endogenous thrombin potential-based activated protein C resistance [44.1% vs. 93.5% (EE/CMA) and 108.1% (EE/DSG)], and in contrast, free protein S levels decreased in the EE/CMA and EE/DSG groups (-12.7% and -4.3%, respectively) but rose in the EE/LNG group (20.4%). In all treatments, total cholesterol, total triglyceride and apolipoproteins increased. Levels of very low-density lipoprotein cholesterol particularly rose across all groups. Slight increases in high-density lipoprotein (HDL) cholesterol were observed for EE/CMA (14.6%) and EE/DSG (8.5%), with a rise above the upper limit of normal in 30% of the subjects taking EE/CMA. Conversely, for EE/LNG slight decreases in HDL cholesterol were observed (-12.4%) lipoprotein (a) levels decreased in the EE/CMA (-6.6%) and EE/LNG (-16.9%) groups and were unchanged in the EE/DSG group.

CONCLUSIONS

The changes observed were typical of those seen across low-dose COCs that differ according to commonly-used progestogens.

Authors+Show Affiliations

Department of Gynaecology and Obstetrics, Clinic of Wetzlar-Braunfels, Wetzlar, Germany. ulrich.winkler@lahn-dill-kliniken.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20399945

Citation

Winkler, Ulrich H., et al. "An Open-label, Comparative Study of the Effects of a Dose-reduced Oral Contraceptive Containing 0.02 Mg Ethinylestradiol/2 Mg Chlormadinone Acetate On Hemostatic Parameters and Lipid and Carbohydrate Metabolism Variables." Contraception, vol. 81, no. 5, 2010, pp. 391-400.
Winkler UH, Röhm P, Höschen K. An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. Contraception. 2010;81(5):391-400.
Winkler, U. H., Röhm, P., & Höschen, K. (2010). An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. Contraception, 81(5), 391-400. https://doi.org/10.1016/j.contraception.2009.12.005
Winkler UH, Röhm P, Höschen K. An Open-label, Comparative Study of the Effects of a Dose-reduced Oral Contraceptive Containing 0.02 Mg Ethinylestradiol/2 Mg Chlormadinone Acetate On Hemostatic Parameters and Lipid and Carbohydrate Metabolism Variables. Contraception. 2010;81(5):391-400. PubMed PMID: 20399945.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. AU - Winkler,Ulrich H, AU - Röhm,Petra, AU - Höschen,Kornelia, Y1 - 2010/01/15/ PY - 2009/08/03/received PY - 2009/12/03/revised PY - 2009/12/05/accepted PY - 2010/4/20/entrez PY - 2010/4/20/pubmed PY - 2010/7/30/medline SP - 391 EP - 400 JF - Contraception JO - Contraception VL - 81 IS - 5 N2 - OBJECTIVE: The study was conducted to compare the effects of 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), given for 24 days each cycle, with those of 0.02 mg EE/0.15 mg desogestrel (DSG) and 0.03 mg EE/0.15 mg levonorgestrel (LNG), given for 21 days each cycle, on hemostatic, lipid, and carbohydrate metabolism parameters in healthy subjects, over six medication cycles. STUDY DESIGN: A randomized, multicentre, open-label, Phase II trial measured markers of hemostasis, and of lipid and carbohydrate metabolism in 165 subjects randomly assigned to treatment with one of three combined oral contraceptives (COCs). RESULTS: EE/CMA and EE/DSG had a similar effect on hemostatic parameters, the EE/LNG group showed comparatively smaller increases in the activity of factor VII [8.1% vs. 36.6% (EE/CMA) and 28.2% (EE/DSG)], protein C [5.9% vs. 32.9% (EE/CMA) and 21% (EE/DSG)] and endogenous thrombin potential-based activated protein C resistance [44.1% vs. 93.5% (EE/CMA) and 108.1% (EE/DSG)], and in contrast, free protein S levels decreased in the EE/CMA and EE/DSG groups (-12.7% and -4.3%, respectively) but rose in the EE/LNG group (20.4%). In all treatments, total cholesterol, total triglyceride and apolipoproteins increased. Levels of very low-density lipoprotein cholesterol particularly rose across all groups. Slight increases in high-density lipoprotein (HDL) cholesterol were observed for EE/CMA (14.6%) and EE/DSG (8.5%), with a rise above the upper limit of normal in 30% of the subjects taking EE/CMA. Conversely, for EE/LNG slight decreases in HDL cholesterol were observed (-12.4%) lipoprotein (a) levels decreased in the EE/CMA (-6.6%) and EE/LNG (-16.9%) groups and were unchanged in the EE/DSG group. CONCLUSIONS: The changes observed were typical of those seen across low-dose COCs that differ according to commonly-used progestogens. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/20399945/An_open_label_comparative_study_of_the_effects_of_a_dose_reduced_oral_contraceptive_containing_0_02_mg_ethinylestradiol/2_mg_chlormadinone_acetate_on_hemostatic_parameters_and_lipid_and_carbohydrate_metabolism_variables_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(09)00523-X DB - PRIME DP - Unbound Medicine ER -