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Laboratory and clinical assessment of a new progestational compound desogestrel a phase i study

Laboratory and clinical assessment of a new progestational compound desogestrel a phase i study

Acta Obstetricia et Gynecologica Scandinavica Suppl. (111): 7-12

The effects of a new progestational compound, desogestrel (17.alpha.-ethynyl-18-methyl-11-methylene-4-estrene-17.beta.-ol), on a range of laboratory and clinical parameters were studied in 3 groups of healthy women (n = 2 - 6) after oral administration of the drug alone (60, 125 or 250 .mu.g) and in combination with 50 .mu.g ethynyl estradiol. 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 table-free cycle. Effects on fasting glucose, triglycerides, total cholesterol, thyroxine, total bilirubin, alkaline phosphatase, alanine aminotransferase, total protein, Hb, thrombocyte count, body wt, 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 ethynyl estradiol.

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