期刊
WOMENS HEALTH
卷 12, 期 3, 页码 325-337出版社
SAGE PUBLICATIONS LTD
DOI: 10.2217/whe-2016-0018
关键词
bremelanotide; female sexual arousal disorder; female sexual dysfunction; FSD; hypoactive sexual desire disorder; HSDD
资金
- Palatin Technologies, Inc.
- Auspex
- Forest Research Institute, Inc.
- Actavis
- Genomind
- Lundbeck
- Pfizer Inc.
- S1 Biopharmaceuticals, Inc.
- Sprout Pharmaceuticals, a division of Valeant
- Abbott
- Allergan
- Astellas
- Eli Lilly
- Evidera
- Ixchelsis
- Pfizer
- Promescent
- Sprout Pharmaceuticals
- S1 Biopharmaceuticals
- Strategic Science Technologies
- Trimel Pharmaceuticals, Inc.
- Vyrix
- Shionogi
- Apricus
- Emotional Brain
- Nuelle
- SST
- TherapeuticsMD
- Materna
- Viveve
- Bayer
- Female Condom Company
- NxThera Inc.
- Lipocine Inc.
- Repros Theraputics
- Apricus BioSciences
- Endo Pharmaceuticals
- Antares Pharmaceuticals
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).
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