TY - JOUR
T1 - Bremelanotide for female sexual dysfunctions in premenopausal women
T2 - A randomized, placebo-controlled dose-finding trial
AU - Clayton, Anita H.
AU - Althof, Stanley E.
AU - Kingsberg, Sheryl
AU - Derogatis, Leonard R.
AU - Kroll, Robin
AU - Goldstein, Irwin
AU - Kaminetsky, Jed
AU - Spana, Carl
AU - Lucas, Johna
AU - Jordan, Robert
AU - Portman, David J.
N1 - Publisher Copyright:
© Anita H Clayton.
PY - 2016/6
Y1 - 2016/6
N2 - 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).
AB - 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).
KW - FSD
KW - HSDD
KW - bremelanotide
KW - female sexual arousal disorder
KW - female sexual dysfunction
KW - hypoactive sexual desire disorder
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U2 - 10.2217/whe-2016-0018
DO - 10.2217/whe-2016-0018
M3 - Article
C2 - 27181790
AN - SCOPUS:84975230200
SN - 1745-5057
VL - 12
SP - 325
EP - 337
JO - Women's Health
JF - Women's Health
IS - 3
ER -