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A 13-month multicenter clinical experience of a low-dose monophasic oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene in Latin American women |
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| Authors: | Bassol Susana Alvarado Gloria Arreola Ranferi Gaona Celis-Gonzalez Cuauhtemoc Peña Efrain Perez Flores Josue Garza Ahued Jose R Ricalde Roger Lara Lopez Carlos R Prieto Gustavo Gurucharri Carlos Heredia Monica G Ortiz Oscar Contreras Percossi Gabriela Figueroa Casas Pedro R Botto Elida Tozzini Roberto Italo Botti Gustavo Nuñez de Pierro Anibal Fernandez Mirta Lastreto Enrique Nañez Monica Carneiro de Oliveira Hildoberto Diogenes Holanda Yazlle Martha E Silva Jaime Salazar German Gomez Jorge Penagos Gloria Cifuentes Rodrigo Torres Luz A Reyes-Marquez Roberto Albrecht Gerhard |
| Affiliation: | a Biomedical Research Centre University of Coahuila, Calle Gregorio A. Garcia 198 Sur, Torreon, Coahuila, Mexico b Reproductive Health Department, Research Institute, Juarez University of Durango, Durango, Mexico c Castelazo Ayala, Ginecobstetric Hospital, IMSS, Mexico City, D. F. Mexico d Occident Medicine Institute, Guadalajara, Jalisco, Mexico e Centre of the Human Reproduction Attendance, A. C. Mexico City, D. F. Mexico f National Institute of Perinatology, Mexico City, D. F. Mexico g Model Institute of Ginaecology and Obstetrics (IMCO), Cordova, Argentina h Ginaecology Service of Medicine School, “Bernardino Rivadavia” Hospital, University of Buenos Aires, Buenos Aires, Argentina i Ginaecology Service of Medicine School, Jose de San Martin Hospital of Clinics, University of Buenos Aires, Buenos Aires, Argentina j Ginaecology Service, “Saenz Peña”, Rosario, Argentina k Centre of Human Reproduction of the Ginaecology Service, Medicine School, Hospital of Centenario, University of Rosario, Rosario, Argentina l Ginaecology Service, “Fernandez Hospital,” Buenos Aires, Argentina m Ginaecology Service of the Junin Private Clinic, Cordova, Argentina n University Hospital, University of State of Rio de Janeiro, Rio de Janeiro, Brazil o Medicine School of Ribeirao Preto, University of Sao Paulo, Sao Paulo, Brazil p San Ignacio University Hospital, Bogota, Colombia q Clinic of Country, Bogota, Colombia r San Jose University Hospital, Bogota, Colombia s San Paul University Hospital, Medellin, Colombia t Del Valle University Hospital, Cali, Colombia u Centro Estrategico Canada Latinoamerica S. A. de C. V. Mexico, Mexico City, D. F. Mexico |
| Abstract: | This prospective, multicenter study was conducted to evaluate the contraceptive reliability, cycle control and tolerability of a 21-day oral contraceptive regimen containing 20 μg ethinylestradiol and 75 μg gestodene in four Latin American countries (Mexico, Argentina, Brazil and Colombia). Participants took trial medication daily for 21 days. Contraceptive efficacy, cycle control and tolerability were evaluated over a period of 13 cycles. Efficacy data gathered from 5,109 treatment cycles were obtained from 393 participants. The trial medication proved to be an effective contraceptive and provided good cycle control. One pregnancy because of poor compliance was recorded. This resulted in a study Pearl index of 0.25. Forty-six percent of Latin American women reported one intracyclic spotting bleeding episode and 37.6% reported one intracyclic breakthrough bleeding (medium/excessive bleeding) episode during cycles 2-4 (primary target). Overall, intracyclic bleeding was reported in 41%. Overall, there was a trend towards a lower incidence of spotting in all the countries and this difference had statistical significance between Argentina and the others three countries (p < 0.05) during cycles 2-4. This trend was also apparent with respect to breakthrough bleeding, but again the difference did not achieve statistical significance. The discontinuation rate because of adverse events was low (3%); no serious adverse events were reported. More than 78% of the women in the four countries maintained constant body weight or lost weight (2 kg) during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study. |
| Keywords: | Oral contraceptives Ethinylestradiol Gestodene Contraceptive efficacy Cycle control Tolerability |
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