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睾酮贴片治疗手术绝经后女性性欲减退障碍的疗效和安全性:一项随机、安慰剂对照试验。

Efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial.

作者信息

Davis Susan R, van der Mooren M J, van Lunsen Rik H W, Lopes Patrice, Ribot Claude, Rees Margaret, Moufarege Alain, Rodenberg Cynthia, Buch Akshay, Purdie David W

机构信息

The Jean Hailes Foundation, Clayton, Australia.

出版信息

Menopause. 2006 May-Jun;13(3):387-96. doi: 10.1097/01.gme.0000179049.08371.c7.

DOI:10.1097/01.gme.0000179049.08371.c7
PMID:16735935
Abstract

OBJECTIVE

Evaluation of the use of testosterone therapy for hypoactive sexual desire disorder (HSDD) after oophorectomy has mostly involved women treated with oral estrogen preparations. We investigated the efficacy and safety of a testosterone patch in surgically menopausal women receiving concurrent transdermal estrogen.

DESIGN

Women with HSDD after oophorectomy, for whom this was a concern, who were using transdermal estrogen, were recruited to a 24-week, randomized, double-blind, placebo-controlled trial in Europe and Australia. Patients were randomly allocated to placebo (n = 40) or testosterone 300 microg/day (n = 37) treatment. Primary endpoints were changes in sexual desire measured by the sexual desire domain of the Profile of Female Sexual Function and the frequency of satisfying sexual activity at 24 weeks.

RESULTS

Sixty-one women (79%) completed the trial. All subjects who received at least one application of study medication were included in analysis. The testosterone-treated group experienced a significantly greater change from baseline in the domain sexual desire score compared with placebo (change from baseline, 16.43 versus 5.98; P = 0.02). The domain scores for arousal, orgasm, decreased sexual concerns, responsiveness, and self-image as well as decreased distress were also significantly greater with testosterone therapy than placebo. The frequency of satisfactory sexual events increased but was not statistically different between treatment groups (P = 0.06) Adverse events occurred with similar frequency in both groups, and no serious risks of therapy were observed

CONCLUSIONS

In this study, transdermal testosterone therapy via a skin patch improved sexual desire and other sexual function domains. It was well tolerated in these oophorectomized women with HSDD receiving concomitant transdermal estrogen.

摘要

目的

对于卵巢切除术后性欲减退障碍(HSDD)使用睾酮疗法的评估,大多涉及接受口服雌激素制剂治疗的女性。我们研究了睾酮贴片在同时接受经皮雌激素治疗的手术绝经女性中的疗效和安全性。

设计

将卵巢切除术后患有HSDD且对此表示担忧、正在使用经皮雌激素的女性招募到欧洲和澳大利亚进行的一项为期24周的随机、双盲、安慰剂对照试验中。患者被随机分配至安慰剂组(n = 40)或300微克/天睾酮组(n = 37)治疗。主要终点为通过女性性功能量表的性欲领域测量的性欲变化以及24周时满意性活动的频率。

结果

61名女性(79%)完成了试验。所有至少接受一次研究药物治疗的受试者均纳入分析。与安慰剂相比,睾酮治疗组在性欲领域得分从基线的变化显著更大(从基线变化,16.43对5.98;P = 0.02)。睾酮治疗组在性唤起、性高潮、性担忧减轻、反应性和自我形象以及痛苦减轻等领域的得分也显著高于安慰剂组。满意性事件的频率增加,但治疗组之间无统计学差异(P = 0.06)。两组不良事件发生频率相似,未观察到严重的治疗风险。

结论

在本研究中,通过皮肤贴片的经皮睾酮疗法改善了性欲和其他性功能领域。在这些接受经皮雌激素治疗的患有HSDD的卵巢切除女性中,其耐受性良好。

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