Desogestrel, a new progestational compound, and the liver.

The short- and long-term effects on the liver of oral contraceptive preparations containing the new progestational compound 13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol (desogestrel) and ethinylestradiol (EE) were studied in multicentre efficacy trials. The following combinations (desogestrel/EE content per daily tablet in micrograms) were investigated: 150/30, 125/50, 100/50 and 75/50, to be taken once daily for 21 days, and a normophasic preparation containing 7 tablets with 50 micrograms EE and 15 tablets containing 125 micrograms desogestrel and 50 micrograms EE. Liver function parameters (SGOT, SGPT, alkaline phosphatase and total bilirubin) were monitored in the serum of 1856 women for periods of up to 36 treatment cycles. The incidence of values (single and combined) above the upper normal limits before treatment was 3.3%. A combination of values above upper normal limits before treatment was observed in 31 women (1.6%). In practically all cases values normalized during treatment; no deterioration was observed. During treatment a combination of values above the upper normal limits was observed in 30 women (having normal pretreatment values); they were distributed over the various preparations and unrelated to the period of contraceptive treatment. The values normalized in the majority of women during the course of treatment. This study shows that with oral contraceptive combinations containing desogestrel and EE (30 or 50 micrograms) liver function is not affected.