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首页> 外文期刊>Gynecological endocrinology: the official journal of the International Society of Gynecological Endocrinology >Safety and tolerability of testosterone patch therapy for up to 4 years in surgically menopausal women receiving oral or transdermal oestrogen.
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Safety and tolerability of testosterone patch therapy for up to 4 years in surgically menopausal women receiving oral or transdermal oestrogen.

机译：在接受口服或经皮雌激素治疗的绝经手术女性中，睾丸激素贴剂疗法的安全性和耐受性长达4年。

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摘要

Two clinical trials previously demonstrated the safety of 300 mug/day transdermal testosterone patch (TTP) treatment for up to 6 months in 1094 surgically menopausal women with hypoactive sexual desire disorder (HSDD). Adverse events (AE), clinical laboratory tests, vital signs, physical examinations and mammograms were evaluated in open-label extensions of these two trials for up to 4 years and are presented in this article. Nine hundred and sixty-seven patients received at least one application of the TTP resulting in 1092 patient-years of exposure. There was no increase over time in the rate of new occurrences or severity of AEs, serious AEs, or withdrawals due to AEs. The most common AEs associated with treatment were application site reactions and unwanted hair growth; however, most were mild and rarely resulted in study withdrawal. No clinically meaningful changes in serum chemistry, haematology, lipid profile, carbohydrate metabolism, renal and liver function or coagulation parameters were noted with up to 4 years of therapy. Consistent with age-appropriate expected rates, three cases of invasive breast cancer were observed. No important changes in the safety or tolerability profile of TTP were revealed with long-term use for up to 4 years in otherwise healthy oophorectomised women with HSDD on concomitant oestrogen.
机译：先前的两项临床试验证明，对1094名患有性欲减退（HSDD）的绝经手术的女性，每天300杯/天的经皮睾丸激素贴剂（TTP）治疗长达6个月是安全的。不良事件（AE），临床实验室检查，生命体征，身体检查和乳房X线照片在这两项试验的开放标签扩展中进行了长达4年的评估，并在本文中进行介绍。 967名患者接受了至少一种TTP施用，导致1092患者-年的暴露。 AE的新发生率或严重性，严重的AE或由于AE引起的戒断的发生率没有随着时间的增加而增加。与治疗相关的最常见不良事件是应用部位反应和多余的毛发生长。但是，大多数是轻度的，很少导致研究退出。长达4年的治疗未发现血清化学，血液学，脂质分布，碳水化合物代谢，肾和肝功能或凝血参数的临床意义变化。与适合年龄的预期比率一致，观察到三例浸润性乳腺癌。长期使用长达4年的其他健康的经卵巢切除并伴有雌激素的经卵巢切除的女性，未发现TTP的安全性或耐受性特征发生重大变化。

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