Profile of a new low dose combination estrogen and progestogen oral contraceptive: a review of nine clinical studies.

A new low dose oral contraceptive containing norgestrel 0.3 mg + ethinyl estradiol 0.030 mg was studied by nine investigators in 1287 women during 11,085 treatment cycles, representing 852 woman-years of usage. The preparation was administered on a cyclic basis -- i.e., tablets were taken for 21 days and then omitted for the last seven days of each cycle. Only one woman conceived, giving a use-effectiveness of 0.12/100 woman-years of treatment. Menstrual irregularities were increased slightly from the pretreatment experience, common side effects usually associated with hormonal therapy were minimal, and the product was highly acceptable to most of the women studied. No drug toxicity was demonstrated, and no malignancy of breasts or pelvic organs, no cardiac, pulmonary, hepatic, or renal disease, and no pulmonary emboli or cerebrovascular disease was reported. The incidence of dropout for medical reasons was 8.9%.