COMPARATIVE-STUDY ON THE EFFICACY, ACCEPTABILITY, AND SIDE-EFFECTS OFA CONTRACEPTIVE PILL ADMINISTERED BY THE ORAL AND THE VAGINAL ROUTE -AN INTERNATIONAL MULTICENTER CLINICAL-TRIAL

The objective of this multicenter randomized clinical trial was to com pare the efficacy, acceptability, and occurrence of side effects assoc iated with the oral versus vaginal route of administration of contrace ptive pills. Eight hundred nineteen healthy, parous women of reproduct ive age were recruited at family planning clinics and research centers , members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly as signed to use either oral or vaginal administration of the same contra ceptive pill, which contained 250 mug levonorgestrel and 50 mug ethiny l estradiol. No statistically significant differences were found in di scontinuation rates between the two groups after 1 year. Involuntary p regnancy rates after 1 year were not statistically significantly diffe rent between the two groups. The vaginal route of administration appea rs to be as acceptable and efficacious as the oral route.