Gestodene: clinical experience with an innovative progestogen used in a combination oral contraceptive preparation.

The contraceptive efficacy, tolerance, and safety of a new monophasic oral contraceptive that combines 75 mcg gestodene (delta-15- levonorgestrel) and 30 mcg ethinyl estradiol were studied in 75 women (944 cycles) currently at risk for pregnancy. 20 women were nulliparous. No woman became pregnant during the trial, nor were vital signs of body weight affected by the drug. Cycle control was excellent, with no bleeding irregularities in 92% of the cycles. Serious complications did not occur. The low incidence of side effects, e.g. headache (9%) and breast tenderness (8%), indicated that the gestodene combination was well-tolerated. In a subgroup of 10 women, no changes in routine laboratory tests could be demonstrated after 12 cycles of treatment.