Male tolerance study of 1% C31G
Male tolerance study of 1% C31G
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DOI：
10.1016/j.contraception.2003.12.008
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发表时间：
2004-09-01
期刊：
影响因子：
2.9
通讯作者：
Bax, R
中科院分区：
文献类型：
--
作者：
Mauck, CK;Frezieres, RG;Bax, R
背景：C31 G作为阴道避孕药和杀微生物剂正在研究中。进行本研究是为了确保女性的男性伴侣在未来的C31 G试验中不会受到阴茎刺激的过度风险。方法：这是一项随机、双盲、单中心I期研究，在包皮环切术和未包皮环切术男性中评估连续7次每日剂量的1.0% C31 G与市售杀精剂相比的阴茎刺激、安全性和可接受性，Extra Strength Gynol II（R）（3% nonoxynol-9）（ES Gynol II）.每名参与者都被要求在睡前将研究产品应用于他的阴茎，6-10小时后将其洗掉，并在日记卡上记录任何症状。在后续的访问，生殖器检查进行，并再次询问参与者的不良事件，并完成一个可接受性questionnaire.Results：在36名男性入组，12.5%的C31 G用户和16.7%的额外强度Gynol II用户报告产品相关的不良事件（AE）。研究者认为所有产品相关AE均为轻度，ES Gynot II组中的1例除外。结论：本研究中使用产品的方式不是男性在实际使用中暴露于此类产品的途径，应根据这一点考虑结果。根据本研究中的观察结果，C31 G似乎至少与市售产品ES Gynol II一样安全且可接受。(C)2004年爱思唯尔公司All rights reserved.
Background: C31G is being studied as a vaginal contraceptive and microbicide. This study was conducted to ensure that male partners of the women in future trials of C31G will not be subjected to an undue risk of penile irritation.Methods: This was a randomized, double-blinded, single-center Phase I study in circumcised and uncircumcised men to assess penile irritation, safety and acceptability of seven consecutive daily doses of 1.0% C31G compared with a marketed spermicide, Extra Strength Gynol II(R) (3% nonoxynol-9) (ES Gynol II). Each participant was instructed to apply the study product to his penis at bedtime, to wash it off 6-10 h later, and to record any symptoms on a diary card. At the follow-up visit, a genital examination was performed and participants were again asked about adverse events and to complete an acceptability questionnaire.Results: Of the 36 men enrolled, 12.5% of C31G users and 16.7% of Extra Strength Gynol II users reported product-related adverse events (AEs). All product-related AEs were considered mild by the investigator, except for one in the ES Gynot II group. Both products were acceptable.Conclusion: The manner in which the products were used in this study is not the route by which men will be exposed to such products in actual use, and results should be considered in this light. Based on the observations in this study, C31G appears to be at least as safe and acceptable for male penile exposure as the marketed product ES Gynol II. (C) 2004 Elsevier Inc. All rights reserved.