Inhibition of ovulation by a novel progestogen (drospirenone) alone or in combination with ethinylestradiol.
OBJECTIVE
To investigate ovulation inhibition with drospirenone, a novel progestogen that has a profile similar to natural progesterone, when given alone or in combination with ethinylestradiol.


METHODS
Hormonal parameters (LH, FSH, 17beta-estradiol and progesterone) and peripheral parameters (cervical score, spinnbarkeit and crystallization), as well as follicle size assessed by ultrasonography, were measured in two groups of healthy women. Forty-eight women aged 19-35 years were randomly assigned to receive 0.5 mg, 1.0 mg, 2.0 mg or 3.0 mg of drospirenone over a single treatment cycle, and 52 women aged 20-35 years were randomized to receive either 2 mg drospirenone/30 microg ethinylestradiol or 3 mg drospirenone/30 microg ethinylestradiol over three treatment cycles. Baseline measurements were taken during a control pretreatment cycle.


RESULTS
Adequate ovarian suppression with drospirenone alone was evident at dose levels of 2 and 3 mg, and at 3 mg all subjects had anovulatory cycles. Although both combined preparations (2 mg and 3 mg drospirenone/30 microg ethinylestradiol) inhibited the hypothalamic-pituitary-ovarian axis, follicular maturation leading to escape ovulation was observed in three subjects in the 2 mg drospirenone/30 microg ethinylestradiol group. Only one of these ovulations was considered to be definitely the result of treatment failure. All cycles in the 3 mg drospirenone/30 microg ethinylestradiol group were anovulatory. No statistically significant difference was found between treatment groups.


CONCLUSIONS
The combination of 3 mg drospirenone/30 microg ethinylestradiol (Yasmin, Schering AG) reliably inhibits ovulation, with a low frequency of follicular maturation, and provides a reasonable safety margin.
Rosenbaum
P
P
Universitätskliniken des Saarlandes, Frauenklinik und Poliklinik, Homburg, Germany.
Schmidt
W
W
Helmerhorst
F M
FM
Wuttke
W
W
Rossmanith
W
W
Freundl
F
F
Thomas
K
K
Grillo
M
M
Wolf
A
A
Heithecker
R
R
D000328:Adult; D000736:Androstenes / Q000494:pharmacology*; D003276:Contraceptives, Oral / Q000494:pharmacology / Q000627:therapeutic use*; D004958:Estradiol / Q000097:blood; D045166:Estradiol Congeners / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000494:pharmacology*; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D010060:Ovulation / Q000187:drug effects*; D011374:Progesterone / Q000097:blood; D045167:Progesterone Congeners / Q000494:pharmacology*
D000736:Androstenes; D003276:Contraceptives, Oral; D045166:Estradiol Congeners; D045167:Progesterone Congeners; D004997:Ethinyl Estradiol; D011374:Progesterone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; C035144:drospirenone