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目的评估十一酸睾酮酯(TU)注射避孕的安全性、有效性、可复性和可接受性。方法 1,045名健康的有生育力的中国男性,每月一次TU 500 mg肌注共30个月,统计分析其配偶的妊娠率、精液参数、睾丸体积、生殖激素水平及安全性评估。结果在6个月的抑制期内有43名对象(4.8%)未达到无精子或严重少精子症;855名对象进入起效期,其中733名完成每月一次TU注射和恢复阶段。在避孕有效期的24个月,暴露1,554/人年中有9次妊娠,累计避孕失败率为1.1/100人;综合失败率6.1%,其中包括1.3%抑制不充分和4.8%短暂抑制后的精子反跳。本研究无严重不良事件报告。除了2名对象以外全部恢复生精功能,达到正常有生育力参考值范围。结论每月一次TU 500 mg肌注可以为健康有生育力的中国男性提供安全、有效、可逆的避孕。
Objective To evaluate the safety, efficacy, refolding and acceptability of contraceptive injection of testosterone undecanoate (TU). Methods 1,045 healthy fertile Chinese men were given intramuscular injection of TU 500 mg once a month for 30 months. The pregnancy rate, semen parameters, testicular volume, reproductive hormone level and safety assessment of their spouses were statistically analyzed. Results 43 subjects (4.8%) did not achieve azoospermia or severe oligospermia during the 6-month repression period; 855 subjects entered the period of onset, of which 733 completed the monthly TU injection and recovery phase. During the 24-month period of contraception, there were 9 pregnancies in 1,554 / person exposures and a cumulative contraceptive failure rate of 1.1 / 100; the overall failure rate was 6.1%, including 1.3% of inadequate inhibition and 4.8% of short-suppressed sperm Anti-jump. No serious adverse events were reported in this study. All but two subjects regained spermatogenic function to achieve normal fertility reference range. CONCLUSIONS: A monthly 500 mg TU administered intramuscularly can provide safe, effective and reversible contraception for healthy and fertile Chinese men.