MODULATION OF OVARIAN-FUNCTION BY AN ORAL-CONTRACEPTIVE CONTAINING 30MU-G ETHINYL ESTRADIOL IN COMBINATION WITH 2.00 MG DIENOGEST

Twenty-two healthy female volunteers with normal ovulatory cycles, age d between 20 and 34 years (27.3 +/- 4.1), were included in a single-ce nter, noncomparative study to investigate the modulation of ovarian fu nction by an oral contraceptive containing 30 mu g ethinyl estradiol i n combination with 2.00 mg dienogest. At baseline, during three treatm ent cycles and post-treatment, serum levels of luteinizing hormone, fo llicle-stimulating hormone, 17 beta-estradiol, and progesterone were a ssayed and ultrasonography was used to measure follicular size and the thickness of the endometrium. The primary efficacy variable was inhib ition of ovulation as measured by ovarian activity grading. All volunt eers ovulated during the pretreatment cycle. During treatment, none of the subjects had ovulatory cycles, although there was still some ovar ian activity in several subjects. During the first treatment cycle, on ly 4% (1 subject) of cycles showed active follicle-like structures. Th e frequency of follicle-like structures increased to 33% and 35% durin g treatment cycles 2 and 3. The frequency of presumptive luteinized un ruptured follicle-like structures was 5% (1 subject) and 15% (3 subjec ts) in treatment cycles 2 and 3. The serum hormone concentrations were effectively suppressed in comparison to baseline. The ovarian activit y returned to baseline during the post-treatment period. One subject w as excluded from further study because of a medical problem believed u nrelated to use of the oral contraceptive. No serious adverse events w ere recorded during the course of the study. The results of the presen t investigation indicate that the modulatory effects on ovarian functi on of the monophasic oral contraceptive containing 30 mu g ethinyl est radiol combined with 2.00 mg dienogest lead to adequate suppression of ovarian activity and effective inhibition of ovulation. (C) 1997 Else vier Science Inc. All rights reserved.