Effect of a combined oral contraceptive containing 3 mg of drospirenone and 30 mu g of ethinyl estradiol on the human endometrium

Objective: To provide an in-depth assessment of the effects of the combined oral contraceptive containing 30 mug of ethinyl estradiol and 3 mg of dros pirenone (Yasmin, Schering AG, Berlin) on the endometrium by means of endom etrial morphometry in comparison to an untreated cycle. Design: The open, multicenter study consisted of one untreated precycle and 13 treatment cycles. Setting: Four gynecologic clinics in Belgium, The Netherlands, and Switzerl and were involved. Patient(s): Forty women with a history of regular menstrual cycles. Intervention(s): Before the commencement of the trial, 3 months without any hormonal intake was obligatory. The first endometrial sample was done in t he untreated precycle, adjusted to the day of LH peak plus 5 to 6 days. Dur ing the medication phase, endometrial samples were taken at cycle 3, 6 and 13. Main Outcome Measure(s): Primary outcome measure of the study was the morph ologic assessment of the endometrium with measures such as glandular diamet er, glandular epithelial height, and number of vacuolated cells per 1,000 g landular cells. Furthermore, the endometrial thickness was measured by ultr asound. Result(s): After 13 cycles of medication use the endometrium had an atrophi c appearance in 63% of the subjects. The size of the glands, the glandular epithelial height, and the number of glands per square millimeter were alre ady significantly reduced after 3 months' use. Histological and ultrasonogr aphical evaluation of the endometrium indicated a suppression of the prolif erative activity of the endometrium. Conclusion(s): The combination of 30 pg of ethinyl estradiol with 3 mg of d rospirenone induces changes of the endometrium that are comparable with oth er combined oral contraceptives and exhibits a marked antiproliferative eff ect on the endometrium. The medication was proven to be an effective oral c ontraceptive and revealed good cycle control characteristics. (C) 2001 by A merican Society for Reproductive Medicine.