Bassol S, Cravioto M C, Durand M, Bailon R, Carranza S, Fugarolas J, Gaona R, Parada L M, Celis C, Santoyo S, Garza-Flores J, Vazquez L, Lopez C, Gurucharri C, Novelli J, Carneiro de Oliveira H, Mendez J, de Andrade M E, de Mello N R, de Melo K, Chada E, Yassle M E, Castañeda A, Gomez P, Arboleda C, Trujillo L, Bucheli R, Hidalgo I, Olavide R, Parejarios J, Succar J, Reyes-Marquez R, Albrecht G
Centro de Investigacion Biomedica Universidad, Autonoma de Coahuila, Mexico.
Contraception. 2000 May;61(5):309-16. doi: 10.1016/s0010-7824(00)00109-8.
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.
对534名有生育能力的拉丁美洲女性进行了一项III期临床研究，以评估一种每月注射一次的复方注射剂Mesigyna（由50毫克庚酸炔诺酮和5毫克戊酸雌二醇组成）的周期控制、副作用和避孕效果。在总计4688个女性月的研究期间，1年的妊娠率为每100女性年0例。1年时的总体停药率为17.9%。因出血问题导致的停药率为5.1%。与其他国家相比，哥伦比亚女性的出血问题显著增加（p<0.001）。闭经导致的停药率为1.1%。在因其他医学或非医学原因停药方面，各组之间无显著差异。使用1年后的平均体重增加为1.02千克。Mesigyna是一种适合拉丁美洲女性的每月注射一次的避孕药物，因为它非常有效，而且其对正常月经出血的感知在拉丁美洲人群中很重要。
