1. Mesigyna once-a-month combined injectable contraceptive: experience in Latin America.
- Author
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Bassol S, Cravioto MC, Durand M, Bailon R, Carranza S, Fugarolas J, Gaona R, Parada LM, Celis C, Santoyo S, Garza-Flores J, Vazquez L, Lopez C, Gurucharri C, Novelli J, Carneiro de Oliveira H, Mendez J, de Andrade ME, de Mello NR, de Melo K, Chada E, Yassle ME, Castañeda A, Gomez P, Arboleda C, Trujillo L, Bucheli R, Hidalgo I, Olavide R, Parejarios J, Succar J, Reyes-Marquez R, and Albrecht G
- Subjects
- Adolescent, Adult, Amenorrhea chemically induced, Blood Pressure, Drug Combinations, Female, Humans, Injections, Latin America, Pregnancy, Uterine Hemorrhage chemically induced, Weight Gain, Contraceptive Agents, Female administration & dosage, Contraceptive Agents, Female adverse effects, Estradiol analogs & derivatives, Norethindrone analogs & derivatives
- Abstract
A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.
- Published
- 2000
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