A multicenter comparative study on the efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant® and Norplant®-II
Por:
Cravioto Ma.D.C., Alvarado G., Canto-De-Cetina T., Bassol S., Oropeza G., Santos-Yung R., Valencia J., Palma Y., Fuziwara J.L., Navarrete T., Garza-Flores J., Pérez-Palacios G.
Publicada:
1 ene 1997
Resumen:
In order to assess efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant® and Norplant®-II in Mexican women, a comparative phase III clinical trial was undertaken in eight clinics across the country. The study involved 1052 women who were followed-up trimonthly for three years. Cumulative pregnancy rates were 0.29% and 0.34% for Norplant and Norplant-II implants, respectively. Similar overall cumulative discontinuation rates were observed at three years: 50.38% for Norplant capsules, and 50.44% for Norplant-II rods. The main method-related reason for termination was endometrial bleeding irregularity which led to discontinuation rates of 11.94% and 11.62% for Norplant and Norplant-II contraceptive systems, respectively. In 15,279 woman-months of experience accumulated with Norplant implants and 14,092 with Norplant-II implants, there were few adverse events reported. No difference was found between the two groups in either difficulty for implants placement and removal or women's discomfort, even though the time required for insertion and removal of Norplant capsules was longer than for Norplant-II rods. It is concluded that during the first three years of use, both implants systems are equally effective, safe, and acceptable.
Filiaciones:
Department of Reproductive Biology, Inst. Nac. de la Nutr. S. Zubiran, México City, Mexico
Department of Reproductive Biology, Natl. Inst. of Nutr. S. Zubiran, Vasco de Quiroga No. 15, México City 14000, Mexico
Inst. de Invest. Científica, Univ. Juarez del Estado de Durango, Durango, Mexico
Ctro. Invest. Regionales Dr. H., Univ. Auton. de Yucatán, Mérida, Mexico
Ctro. de Invest. Biomédica, Univ. Autónoma de Coahuila, Torreón, Mexico
Hospital General de México, Secretaría de Salud, México City, Mexico
Hosp. Dr. Manuel Gea-González, Secretaría de Salud, Méxco City, Mexico
Fund. Mexicana Planeacion Familiar, México City, Mexico
Dir. Gen. de Planificacion Familiar, Secretaría de Salud, México City, Mexico
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