摘要
目的 对十一酸睾酮酯 ( TU)注射液的安全性、避孕有效性和可复性进行临床多中心评估。 方法 本研究采用 WHO规定的监测指标 ,是一个前瞻性、开放式和多中心的临床 II期男性激素避孕药有效性试验。 3 0 8名年龄 2 5～ 45岁的正常男性志愿者 ,筛选合格后被纳入此项临床试验。 结果 9名受试者在 6个月的抑制期内未能达到无精子或严重少精子症 ,其原发避孕失败率为 2 .9/ 1 0 0人年。 2 96名受试者进入避孕有效期。除 1名受试者因精子反跳其配偶发生妊娠外 ,无精子或严重少精子症的受试者配偶未发生妊娠。 6名受试者发生精子反跳 ,导致的继发避孕失败率为 2 .3 / 1 0 0人年。避孕总失败率为 5.2 / 1 0 0人年 ,避孕有效率为 94.8%。除 2 0名受试者因失访退出研究外 ,其余受试者在恢复期内精子均达到基础值水平或正常参考值范围。 结论 每月注射 50 0 mgTU能够有效地抑制中国人的精子发生 ,无严重不良反应。
Objective: To evaluate the safety, efficacy and reversibility of injectable testosterone undecanoate (TU) in normal Chinese men by a multicenter clinical trial. Methods: A total of 308 eligible normal volunteers were recruited into this study. This project was a prospective, phase II, open label and multicenter clinical trial of male hormonal contraception with WHO standard monitoring. Results: Nine subjects did not achieve azoospermia or severe oligozoospermia within the 6 month suppression phase, which gave a methodological failure rate of 2.9 per 100 couple year. Two hundred and ninety six man entered into the efficacy phase. No woman was impregnated with man who achieved azoospermia or severe oligozoospermia. Reappearance of sperm occurred in 6 men during the efficacy phase and one pregnancy was attributed to this kind of sperm rebound. This gave a secondary failure rate of 2.3 per 100 couple year. Thus, total failure rate was 5.2% and total efficacy was 94.8%. Spermatogenesis in all subjects except 20 lost to follow up returned to normal reference range within the recovery period. Conclusion: Monthly TU injection at dose of 500 mg can effectively, safely and reversibly suppress spermatogenesis in healthy Chinese men without serious adverse effects.
出处
《生殖医学杂志》
CAS
2003年第2期67-73,共7页
Journal of Reproductive Medicine
基金
世界卫生组织合作课题 (95 80 1)
国家"九五"科技攻关课题 (96 - 90 4 - 0 4 - 0 1)
关键词
十一酸睾酮酯
注射液
避孕
有效性
临床研究
Male contraception
Testosterone undecanoate
Sperm concentration
Azoospermia
Oligozoospermia
