An introductory trial with the injectable contraceptive Cyclofem was carried out in Brazil, Chile, Colombia, and Peru, with participation by 3,183 women. Women were followed-up for up to 2 years of use and the data were evaluated by life table analysis. A total of 29,676 women-months were accumulated for up to 2 years. No pregnancies were observed in the 2 years. The discontinuation rates for amenorrhea in the first year ranged from 3.4 in Brazil to 8.1 in Colombia, and for menstrual disturbances from 5.1 in Chile to 9.2 in Brazil. The discontinuation rates for other medical reasons ranged from 7.8 in Brazil to 26.3 in Colombia, and for personal reasons from 17.2 in Chile to 23.5 in Brazil. Continuation rates ranged from 42.3 in Colombia to 52 in Chile. In the second year of observation the rates of discontinuation were lower than those observed in the first year, with the exception of personal reasons in Brazil, which were the same as those observed in the first year. Continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. The comparison of reasons for discontinuation in selected clinics showed that the rate for amenorrhea in one clinic in Chile was more than three times that in others and in Peru was seven times more in one clinic than in another. Regarding menstrual disturbances, in Peru one clinic presented a rate three times higher than the others. The main reasons for discontinuation due to other medical reasons were headache and weight gain. In conclusion, Cyclofem presented a high contraceptive efficacy and an acceptable rate of continuation and discontinuation for up to 2 years in the four countries.
PIP: The performance of the monthly injectable contraceptive, Cyclofem, was evaluated in an introductory trial involving 3183 women recruited from family planning centers in Brazil, Chile, Colombia, and Peru. A total of 29,676 women-months of use were accumulated during up to 2 years of follow-up. No pregnancies occurred during the study period. Discontinuation rates per 100 women in the first year ranged from 3.4 in Brazil to 8.1 in Colombia for amenorrhea and from 5.1 in Chile to 9.2 in Brazil for menstrual disturbances. The discontinuation rate for other medical reasons (primarily headache, weight gain, and acne) ranged from 7.8 in Brazil to 26.3 in Colombia and for personal reasons from 17.2 in Chile to 23.5 in Brazil. First-year continuation rates ranged from 42.3 in Colombia to 52.0 in Chile. In the second year of use, continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. Upon receiving these results, national regulatory authorities in the 4 participating countries approved Cyclofem registration. Acceptance of injectable contraception, which currently entails administration of the method by a service provider and travel to a clinic, could be improved in developing countries by training in self-administration.