Meriggiola M C, Bremner W J, Costantino A, Di Cintio G, Flamigni C
Department of Obstetrics and Gynecology and Core Lab, S.Orsola Hospital, University of Bologna, Italy.
Hum Reprod. 1998 May;13(5):1225-9. doi: 10.1093/humrep/13.5.1225.
After a control phase, 10 normal men received cyproterone acetate (CPA) at a dose of 25 mg/day (CPA-25; n=5) or 12.5 mg/day (CPA-12.5; n=5) plus testosterone enanthate (TE) 100 mg/week, for 16 weeks. Throughout the study sperm counts were performed every 2 weeks, and luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone, biochemical and haematological tests were performed every 4 weeks. All five men in group CPA-25 and three men in group CPA-12.5 achieved azoospermia. One man in group CPA-25 was azoospermic by week 12 of hormone administration, but had a sperm count of 0.1 x 10(6)/ml at week 16. Time to azoospermia was 9.0+/-1.3 and 8.7+/-0.7 weeks in groups CPA-25 and CPA-12.5 respectively. Gonadotrophins were decreased by week 4 of hormone administration, remained around the minimum detectability of the assay for the duration of hormone administration and returned to baseline after stopping hormone administration. Testosterone values did not change. No change in any biochemical parameters was found. Haematological parameters were decreased at week 16 of hormone administration and returned to baseline after stopping hormone administration. In conclusion, these results suggest that an hormonal regimen consisting of testosterone plus a progestin with anti-androgenic properties holds promise as an effective, safe and reversible male contraceptive.
在一个对照阶段之后,10名正常男性接受了醋酸环丙孕酮(CPA)治疗,剂量为25毫克/天(CPA - 25组;n = 5)或12.5毫克/天(CPA - 12.5组;n = 5),外加庚酸睾酮(TE)100毫克/周,持续16周。在整个研究过程中,每2周进行一次精子计数,每4周进行一次促黄体生成素(LH)、促卵泡生成素(FSH)、睾酮、生化和血液学检测。CPA - 25组的所有5名男性以及CPA - 12.5组的3名男性均达到无精子症。CPA - 25组的一名男性在激素给药第12周时无精子,但在第16周时精子计数为0.1×10⁶/毫升。CPA - 25组和CPA - 12.5组达到无精子症的时间分别为9.0±1.3周和8.7±0.7周。激素给药第4周时促性腺激素下降,在激素给药期间一直维持在检测方法的最低可检测水平左右,停止激素给药后恢复到基线水平。睾酮值没有变化。未发现任何生化参数有改变。血液学参数在激素给药第16周时下降,停止激素给药后恢复到基线水平。总之,这些结果表明,由睾酮加具有抗雄激素特性的孕激素组成的激素方案有望成为一种有效、安全且可逆的男性避孕药。