Imperial College Hospitals & Chelsea and Westminster Hospital, London, UK.
Climacteric. 2010 Apr;13(2):121-31. doi: 10.3109/13697131003675922.
To evaluate the efficacy and safety of a transdermal testosterone patch (TTP, 300 microg/day) in naturally menopausal women with hypoactive sexual desire disorder (HSDD).
A total of 272 naturally menopausal women, predominantly not using hormone therapy, were randomized in this 6-month, placebo-controlled, double-blind, multicenter study to receive twice weekly either TTP or an identical placebo. Efficacy endpoints measured were the 4-week frequency of satisfying sexual episodes (SSE) using the Sexual Activity Log, the sexual desire domain of the Profile of Female Sexual Function and distress by the Personal Distress Scale. Safety was assessed by adverse events, laboratory parameters and hormone levels.
The TTP group demonstrated significant improvements in SSE (p = 0.0089) as well as in sexual desire (p = 0.0007) and reduced personal distress (p = 0.0024) versus placebo at 6 months (intent-to-treat analysis, n = 247). The results were significant for all three endpoints in the subgroup (n = 199) not using hormone therapy. Similar numbers of women treated with placebo and TTP discontinued (n = 39, 27.5% vs. n = 26, 20%), reported adverse events (including application site reactions) (n = 101, 71.1% vs. n = 81, 62.3%) and withdrew due to adverse events (n = 20, 14.1% vs. n = 9, 6.9%). No clinically relevant changes were noted in laboratory parameters. Serum free and total testosterone levels increased from baseline in the TTP group (geometric means 5.65 pg/ml and 67.8 ng/dl, respectively, at week 24) within the physiological range; no changes were seen in estradiol and sex hormone binding globulin levels.
TTP was effective in treating HSDD and improving sexual function in this study of naturally menopausal women with and without concurrent hormone therapy.
评估经皮睾酮贴片（TTP，300 微克/天）治疗自然绝经、低性欲障碍（HSDD）女性的疗效和安全性。
这项为期 6 个月、安慰剂对照、双盲、多中心研究共纳入 272 例自然绝经、主要不接受激素治疗的女性，随机分为两组，每周接受 2 次 TTP 或安慰剂治疗。采用性活动日志（Sexual Activity Log）评估 4 周满意性事件（SSE）频率，用女性性功能量表（Female Sexual Function）的性欲维度和个人苦恼量表（Personal Distress Scale）评估性欲望和苦恼程度。通过不良反应、实验室参数和激素水平评估安全性。
治疗 6 个月时，TTP 组 SSE（p = 0.0089）、性欲（p = 0.0007）和个人苦恼（p = 0.0024）均显著改善，而安慰剂组无显著变化（意向治疗分析，n = 247）。在未接受激素治疗的亚组（n = 199）中，所有 3 个终点均有显著改善。接受安慰剂和 TTP 治疗的女性停药人数相近（n = 39，27.5% vs. n = 26，20%），报告不良反应（包括贴剂部位反应）人数相近（n = 101，71.1% vs. n = 81，62.3%），因不良反应停药人数相近（n = 20，14.1% vs. n = 9，6.9%）。实验室参数无临床相关变化。TTP 组治疗 24 周时血清游离和总睾酮水平分别从基线升高（几何均数分别为 5.65 皮克/毫升和 67.8 纳克/分升），处于生理范围；雌二醇和性激素结合球蛋白水平无变化。
TTP 治疗自然绝经、合并或不合并激素治疗的 HSDD 女性有效，可改善性功能。
