title: Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.
abstract: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women.
  
  
  
  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.
  
  
  
  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.
  
  
  
  In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).
authors.affiliation: University of Virginia, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903, USA.
authors.forename: Anita H
authors.initials: AH
authors.lastname: Clayton
authors.affiliation: Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
authors.forename: Stanley E
authors.initials: SE
authors.lastname: Althof
authors.affiliation: University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
authors.forename: Sheryl
authors.initials: S
authors.lastname: Kingsberg
authors.affiliation: Maryland Center for Sexual Health, 1300 York Road, Lutherville, MD 21093, USA.
authors.forename: Leonard R
authors.initials: LR
authors.lastname: DeRogatis
authors.affiliation: Seattle Women's Health, Research, Gynecology, 3216 NE 45th Place, Seattle, WA 98105, USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Kroll
authors.affiliation: San Diego Sexual Medicine/Alvarado Hospital & Medical Center, 6655 Alvarado Road, San Diego, CA 92120, USA.
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.affiliation: Manhattan Medical Research, 215 Lexington Avenue, New York, NY 10016, USA.
authors.forename: Jed
authors.initials: J
authors.lastname: Kaminetsky
authors.affiliation: Palatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
authors.forename: Carl
authors.initials: C
authors.lastname: Spana
authors.affiliation: Palatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
authors.forename: Johna
authors.initials: J
authors.lastname: Lucas
authors.affiliation: Palatin Technologies, Inc., 4C Cedar Brook Drive, Cranbury, NJ 08512, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Jordan
authors.affiliation: Columbus Center for Women's Health Research, 99 North Brice Road, Columbus, OH 43213, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Portman
mesh_terms: D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007989:Libido / Q000187:drug effects*; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000008:administration & dosage*; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy*; D016896:Treatment Outcome; D016387:Women's Health; D000521:alpha-MSH / Q000008:administration & dosage*
chemical_list: D010456:Peptides, Cyclic; D000521:alpha-MSH; C476721:bremelanotide
keywords: FSD; HSDD; bremelanotide; female sexual arousal disorder; female sexual dysfunction; hypoactive sexual desire disorder