Using a low-dose contraceptive in women 35 years of age and over: 20 microg estradiol/100 microg levonorgestrel.

The efficacy, safety, and cycle control of a low-dose oral contraceptive (OC) containing 20 microg ethinyl estradiol (EE) and 100 microg levonorgestrel (LNG) has been demonstrated in a large trial with 1708 women (>or=15 years old with regular menstrual cycles). The objective of this study was to analyze the same parameters in 218 of the 1708 women who were 35 years of age and older. Women were administered the 28-day, combination OC (20 microg EE/100 microg LNG; 21 days active medication/7 days placebo) for up to 3 years. During 3859 cycles evaluated for efficacy, one pregnancy occurred (Pearl index 0.34). The most common adverse events cited as reasons for discontinuation were hypertension (3% of subjects), headache (2%), and metrorrhagia (2%). One subject withdrew as a result of a serious adverse event. Breakthrough bleeding, spotting, and bleeding and spotting occurred in 2.9%, 11.0%, and 6.8%, respectively, of the 3739 cycles evaluated for cycle control. This low-dose, monophasic regimen of 20 microg EE/100 microg LNG is an effective, safe, and tolerable contraceptive and provides good cycle control for women 35 years of age and older.