Liver Function Tests during Use of Three-phaseContraception with Norgestimate

Overview

Objective:
To evaluate serum levels of liver enzymes and bilirubin before and after six cycles ofuse of a triphasic oral contraceptive containing 35 mg of ethinylestradiol and 180/215/250 mg ofnorgestimate (Pramino ® , Janssen-Cilag).Design: A prospective, open-label, non-comparative, multicentric phase IV study.Setting: Department of Obstetrics and Gynaecology, 1 st Medical Faculty, Charles University, Pra-gue.Method: Before the start and after six cycles of Pramino use, the levels of alanine aminotransfera-se (ALT), aspartate aminotransferase (AST), g-glutamyltransferase (GMT), and bilirubin were de-termined in women. As the analyses were performed in different laboratories, the evaluationinvolved: 1. Subgroups of women examined in laboratories with the same reference range; 2.A group of women examined in laboratories with the upper reference range within the mean ± SDinterval; 3. Percentage variations of the measured values from a concrete upper reference limit.Results: When evaluating subgroups of women from laboratories with the same standards, signifi-cant decreases in AST and bilirubin were seen in some subgroups, a rise in GMT in one subgroup;the other changes were non-significant. When assessing the entire group and percentage variati-ons from standard, a mild rise in GMT was again seen; however, the values remain deep withinthe normal range. Values above the upper reference limit at the start of the study either do notchange significantly throughout the study, or they normalize spontaneously.Conclusion: No clinically significant changes in liver function tests occurred in users of a tripha-sic oral contraceptive containing norgestimate along with 35 mg EE over a period of six cycles ofuse. The results, as judged by their dynamics, suggest liver function tests are not a useful tool forroutine monitoring a healthy combined oral contraceptive user.

Key words:
hormonal contraception, liver function tests, alanine aminotransferase, aspartate ami-notransferase, g-glutamyltransferase