RESUMO
A large introductory study of Cyclofem, a once-a-month injectable contraceptive, was conducted in three Mexican provinces. A total of 3457 healthy women participated: 640 women from rural areas (community-based component) and 2817 women from urban and suburban areas (health center-based component). A total of 20,316 women-months of treatment experience were accumulated during a one year period. Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%. Higher continuation rates were observed in the community-based component (36.6%) as compared to the health center component (23.7%). The most common reason for method discontinuation was change of address. Only 15% of the discontinuations were attributable to the injectable contraceptive method, with the overall 1 year discontinuation rate for bleeding problems (including amenorrhea) was < 11%. These observations underscore the importance of appropriate counseling and follow-up measures, providing convenient access to repeat injections, and other service delivery issues related to continuation of Cyclofem. The results of this trial have once again demonstrated that Cyclofem is a highly effective method with an acceptable side effect profile. In addition, the study provided the elements for its approval by local health authorities and its inclusion into the Ministry of Health Family Planning Program.
PIP: The effectiveness and continuation rates associated with the once-a-month injectable contraceptive Cyclofem were investigated in an introductory trial conducted in three Mexican provinces (Sinaloa, Guanajuato, and Veracruz). Cyclofem contains 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate. A total of 3457 women (640 women from rural communities and 2817 from urban and suburban family planning centers) were enrolled and 20,316 woman-months of treatment experience were accumulated during the 12-month study period. The mean age of study participants was 23.6 years; 70% had previously used at least one contraceptive method. There was only one pregnancy (rate, 0.03%). The overall life-table continuation rate at 1 year was 26.1%, but this rate was higher in the community-based group (36.9%) than in the health center group (22.4%). This discrepancy is presumed to reflect the greater access of clinic clients to other contraception options. Continuation was highest among women 30-34 years of age, those with low levels of education, women with five or more children, and those who did not want more children. Only 14% of discontinuations were method-related. The 1-year discontinuation rate for bleeding problems, including amenorrhea, was 10.2%. These findings indicate Cyclofem is a safe, effective method appropriate for inclusion in Mexico's Ministry of Health Family Planning Program.