Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial
Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial
复制标题
布雷美诺肽治疗绝经前女性性功能障碍：随机安慰剂对照剂量试验
DOI：
10.2217/whe-2016-0018
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发表时间：
2016-06-01
期刊：
影响因子：
2.4
通讯作者：
Portman, David J.
中科院分区：
文献类型：
--
作者：
Clayton, Anita H.;Althof, Stanley E.;Portman, David J.
目的：评价布雷默浪肽（BMT），一种黑皮质素受体-4激动剂，治疗绝经前女性性功能障碍的有效性/安全性。方法：患者随机接受安慰剂或BMT 0.75，1.25或1.75 mg皮下自我给药，根据需要，超过12周。主要终点是每月满意性事件的变化。次要终点包括女性性功能指数和女性性困扰量表-欲望/唤醒/性高潮的总分变化。结果：疗效数据，n = 327。对于1.25/1.75 mg汇总组与安慰剂组，从基线至研究结束的平均变化分别为+0.7 vs +0.2满意性事件/月（p = 0.0180），女性性功能指数总分为+3.6 vs +1.9（p = 0.0017），-11.1 vs. -6.8女性性困扰量表-欲望/唤起/高潮总分（p = 0.0014）。不良事件：恶心、潮红、头痛。结论：在患有女性性功能障碍的绝经前女性中，根据需要自我给药皮下BMT安全、有效且耐受性良好（NCT 01382719）。
Aim: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women. Methods: Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sexual function index and female sexual distress scale-desire/arousal/orgasm. Results: Efficacy data, n = 327. For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180), +3.6 versus +1.9 female sexual function index total score (p = 0.0017), -11.1 versus -6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014). Adverse events: nausea, flushing, headache. Conclusion: In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).