Zhang Liying, Shah Iqbal H, Liu Yunrong, Vogelsong Kirsten M, Zhang Lihong
National Research Institute for Population and Family Planning, Research Center of Social Medicine, Beijing 100081, China.
Contraception. 2006 May;73(5):548-53. doi: 10.1016/j.contraception.2005.10.012. Epub 2006 Jan 20.
An acceptability study of an injectable preparation of the synthetic steroid testosterone undecanoate as a once-a-month male contraceptive method was carried out concurrently with, but independently from, a clinical safety and efficacy trial of this preparation in China, from 1997 to 1999.
Three hundred eight men, the entire group of volunteers enrolled in the clinical trial, were interviewed using a structured questionnaire. In addition, 24 sessions of focus group discussions and 54 in-depth interviews were conducted with a broad range of stakeholders, including men enrolled in the trial and their wives, potential users, service providers, principal investigators of the six participating clinical trial centers, provincial and national policy makers, and experts engaged in research and development of male methods of contraception.
Overall, men found the regimen to be acceptable, and most reported no change or an improvement in their well-being as a result of participating in the clinical study. The frequency of the injections, monthly semen analyses and the need to use another contraceptive method during the period of sperm suppression were reported inconveniences of the trial.
Further research is needed to assess the long-term safety, continuation rates, satisfaction among users and issues related to service delivery.
1997年至1999年,在对合成类固醇十一酸睾酮注射制剂进行中国临床试验的安全性和有效性研究的同时,独立开展了一项关于该制剂作为每月一次男性避孕方法的可接受性研究。
使用结构化问卷对参与临床试验的308名男性志愿者进行了访谈。此外,还与广泛的利益相关者进行了24次焦点小组讨论和54次深入访谈,这些利益相关者包括参与试验的男性及其妻子、潜在使用者、服务提供者、六个参与临床试验中心的主要研究者、省级和国家政策制定者以及从事男性避孕方法研发的专家。
总体而言,男性认为该方案是可接受的,大多数人报告称参与临床研究后其幸福感没有变化或有所改善。注射频率、每月精液分析以及在精子抑制期需要使用另一种避孕方法被报告为试验中的不便之处。
需要进一步研究以评估长期安全性、持续使用率、使用者满意度以及与服务提供相关的问题。