Abstract
The effects of a new progestational compound, desogestrel (17α-ethinl-18-methyl-11-methylene-4-estrene-17β-01), on a range of laboratory and clinical parameters have been studied in three groups of healthy women (n = 2–6) after oral administration of the drug alone (60, 125, or 250 μg) and in combination with 50 μg ethinylestradiol. The time for each group to enter the study was staggered so that any undesirable side effect could be recognized before a higher concentration of desogestrel was given. Tablets were administered for 21 days and, for control reasons, each treatment cycle was preceded by a tablet-free cycle. Effects on fasting glucose, triglycerides, total cholesterol, thyroxine, total bilirubin, alkaline phosphatase, ala-nine aminotransferase, total protein, hemoglobin, throm-bocyte count, body weight, blood pressure and bleeding pattern were studied. In addition any effect on the general physical well-being of the volunteers was recorded. The results of the study have not revealed any adverse effects on laboratory or clinical parameters and justify further clinical investigations with desogestrel, both alone and in combination with ethinylestradiol.