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Wyeth-Ayerst introduces Alesse; OC expands range of low-dose pills.


 Wyeth-Ayerst Laboratories recently introduced Alesse, a 20 mcg monophasic oral contraceptive pill available in 21- and 28-day regimens. The pill is comprised of 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel. Alesse was recently cleared for release by the US Food and Drug Administration (USFDA). A multicenter clinical trial involving 1477 women aged 17-49 years found the pill to provide good cycle control. Headache was the most common side effect noted by women in the trial. The only other 20 mcg pill, Loestrin 1/20, manufactured by Parke-Davis, also uses ethinyl estradiol for its estrogen, but 1 mg of norethindrone acetate as its progestin. The availability of such low-dose pills is particularly important for women in their later contraceptive years. These women may need contraception as well as relief from perimenopausal symptoms. The USFDA also cleared Alesse for use as an emergency contraceptive pill, the seventh brand approved by the agency for such use.
