The low-dose
combined oral contraceptive of ethinylestradiol 30 microg and
dienogest 2 mg was launched in Germany in 1995, and is now the most commonly prescribed
oral contraceptive in this country.
Dienogest is a novel 19-nortestosterone-derived
progestin with a unique pharmacokinetic and pharmacological profile, including antiandrogenic properties. Clinical studies have demonstrated that ethinylestradiol/
dienogest is a reliable ovulation inhibitor with high
contraceptive efficacy that is comparable with other
combined oral contraceptives. It also provides effective cycle control, with reduced intensity and duration of menstrual
bleeding, and improves dysmenorrhoea. The combination of ethinylestradiol and
dienogest reduces serum
androgen levels, and increases the levels of
thyroid hormones; however, although
thyroid hormone levels increase, there is no increased activity due to increases in transporter
protein. Like other
low-dose oral contraceptives, ethinylestradiol/
dienogest has only minor influences on
lipid and carbohydrate metabolism, adrenal
hormones and blood pressure parameters, and appears to have a balanced effect on the haemostatic system. Ethinylestradiol/
dienogest also has beneficial effects on hair and skin; a number of studies have reported decreased hair and skin greasiness, and improvements in
acne vulgaris following treatment with ethinylestradiol/
dienogest. After discontinuation of ethinylestradiol/
dienogest, there may be a small delay in conception during the first three cycles, but there is no subsequent impairment of fertility. Furthermore, the duration of use of ethinylestradiol/
dienogest does not seem to influence the rate of conception or time to conception. Ethinylestradiol/
dienogest is well tolerated; adverse reactions associated with treatment include
breast pain,
headache and
nausea/
vomiting. These adverse reactions are rare and decrease in incidence over time.