Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial
AH Clayton, SE Althof, S Kingsberg… - Women's …, 2016 - journals.sagepub.com
AH Clayton, SE Althof, S Kingsberg, LR DeRogatis, R Kroll, I Goldstein, J Kaminetsky…
Women's Health, 2016•journals.sagepub.comAim: 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 …
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 …
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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