Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial

被引：67

作者：

Clayton, Anita H. ^{[1
]}

Althof, Stanley E. ^{[2
]}

Kingsberg, Sheryl ^{[3
]}

DeRogatis, Leonard R. ^{[4
]}

Kroll, Robin ^{[5
]}

Goldstein, Irwin ^{[6
]}

Kaminetsky, Jed ^{[7
]}

Spana, Carl ^{[8
]}

Lucas, Johna ^{[8
]}

Jordan, Robert ^{[8
]}

Portman, David J. ^{[9
]}

机构：

[1] Univ Virginia, 2955 Ivy Rd,Northridge Suite 210, Charlottesville, VA 22903 USA

[2] Case Western Reserve Univ, Sch Med, 11100 Euclid Ave, Cleveland, OH 44106 USA

[3] Univ Hosp Case Med Ctr, 11100 Euclid Ave, Cleveland, OH 44106 USA

[4] Maryland Ctr Sexual Hlth, 1300 York Rd, Lutherville Timonium, MD 21093 USA

[5] Seattle Womens Hlth, Res, Gynecol, 3216 NE 45th Pl, Seattle, WA 98105 USA

[6] Alvarado Hosp & Med Ctr, San Diego Sexual Med, 6655 Alvarado Rd, San Diego, CA 92120 USA

[7] Manhattan Med Res, 215 Lexington Ave, New York, NY 10016 USA

[8] Palatin Technol Inc, 4C Cedar Brook Dr, Cranbury, NJ 08512 USA

[9] Columbus Ctr Womens Hlth Res, 99 North Brice Rd, Columbus, OH 43213 USA

来源：

WOMENS HEALTH | 2016年 / 12卷 / 03期

关键词：

bremelanotide; female sexual arousal disorder; female sexual dysfunction; FSD; hypoactive sexual desire disorder; HSDD;

D O I：

10.2217/whe-2016-0018

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

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).

引用

页码：325 / 337

页数：13

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