COMPARATIVE-STUDY ON INTERMITTENT VERSUS CONTINUOUS USE OF A CONTRACEPTIVE PILL ADMINISTERED BY VAGINAL ROUTE

A multicenter, international, randomized, comparative trial was conduc ted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 mu g levonorgestrel and 50 mu g ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interrup tion to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruite d in three countries, Brazil, Egypt and China; 7,090 women-months of v aginal pill use were recorded (3,364 using the pills intermittently an d 3, 726 continuously). Four undesired pregnancies occurred, one in Eg ypt and three in China, ah four in women using the pills intermittentl y. There was a statistically significant difference (p=0.486) in pregn ancy rate between the two groups. There were no other significant diff erences in discontinuation rates despite marked differences in bleedin g patterns, amenorrhea predominating in the continuous use group. Hemo globin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.