Clinical trial of gestoden

The new progestin gestodene has low intrinsic androgenicity and strongly suppresses ovarian activity without negatively affecting lipid metabolism. Gestodene is a derivative of 19-nortestosterone and is used in a triphasic formulation. 31 women used the triphasic for a total of 442 cycles at a family planning service in Caracas Venezuela. The number of cycles per user varied from 1 to 24 and averaged 14.2. The total steroid dose of the triphasic pills containing gestodene is only 2.33 mg per cycle. The 1st 6 pills contain 50 mcg of gestodene and 30 mcg of ethinyl estradiol (EE) the next 5 pills contain 70 mcg of gestodene and 40 of EE and the final 10 contain 100 mcg of gestodene and 30 of EE. The patients ranged in age from 15-34 and had an average of 1.4 pregnancies. 9 smoked and 1 drank alcohol. In the 442 cycles studied there were no cases of pregnancy or amenorrhea. Intermenstrual bleeding and spotting not due to errors of pill administration were reported in 6.5% and 3.2% of cycles respectively in the 1st trimester of use. There were no significant variations in blood pressure or body weight. In the area of subjective side effects patients with dysmenorrhea reported improvement and those with breast tenderness reported persistence. The triphasic containing gestodene appears to combine the advantages of a low steroid dose efficacy and excellent tolerance and cycle regulation.