Division of Endocrinology, Department of Medicine, General Clinical Research Center, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute (LA BioMed) at Harbor-UCLA Medical Center, Torrance, CA 90509, USA.
Contraception. 2010 Nov;82(5):471-5. doi: 10.1016/j.contraception.2010.03.010. Epub 2010 May 21.
Landmark WHO-sponsored trials showed decades ago that male hormonal contraception (MHC) is an effective male-directed contraceptive approach. Considerable progress has been made particularly in the last 5 years, establishing for the first time the reversibility of MHC and its short-term safety. Methodological advances in recent years include the pooling of information and individual-level integrated analysis; the first-time use of centralized semen analysis and fluorescence to detect low sperm concentrations; the establishment of sperm quality reference ranges in fertile men; the measurement of blood steroid concentrations by gas chromatography/mass spectrometry; and the inclusion of placebo groups to delineate clearly possible adverse effects of androgens and progestins in men. We report integrated analyses of factors that are important in predicting suppression and recovery of spermatogenesis after MHC clinical trials for the past 15 years. These are the best data available and will provide guidance and reassurance for the larger-scale Phase III specific regimen efficacy studies that will be required to bring MHC to the population (market).
几十年前，世界卫生组织（WHO）赞助的具有里程碑意义的试验表明，男性激素避孕（MHC）是一种有效的男性导向避孕方法。特别是在过去的 5 年中取得了相当大的进展，首次证实 MHC 的可逆性及其短期安全性。近年来方法学的进步包括信息的汇集和个体水平的综合分析；首次使用集中化精液分析和荧光检测低精子浓度；建立了生育男性精子质量参考范围；通过气相色谱/质谱法测量血液类固醇浓度；并纳入安慰剂组，以明确雄激素和孕激素对男性可能产生的不良反应。我们报告了过去 15 年 MHC 临床试验中预测精子发生抑制和恢复的重要因素的综合分析。这些是目前可获得的最佳数据，将为更大规模的 III 期特定方案疗效研究提供指导和保证，这些研究将需要 MHC 应用于人群（市场）。
