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S. Kingsberg, A. Clayton, D. Portman, R. Jordan, D. Revicki, L. Williams, J. Krop, 020 Bremelanotide Treatment Provided Clinically Meaningful Benefits in Premenopausal Women With Hypoactive Sexual Desire Disorder, The Journal of Sexual Medicine, Volume 17, Issue Supplement_1, January 2020, Pages S9–S10, https://doi.org/10.1016/j.jsxm.2019.11.023
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Introduction
Hypoactive sexual desire disorder (HSDD) is the most common sexual dysfunction in women, and is characterized by an absence or deficiency of sexual desire accompanied by distress. HSDD affects approximately 10% of women, with a similar prevalence regardless of age or country. Bremelanotide, a melanocortin receptor agonist and an analog of the endogenous neuropeptide α-melanocortin stimulating hormone, is approved for the treatment of acquired, generalized HSDD in premenopausal women. The RECONNECT studies (Studies 301 and 302), which comprised two identically designed, double-blind, randomized, placebo-controlled studies, demonstrated that subcutaneous self-administration of bremelanotide, as needed, significantly improved sexual desire and decreased related personal distress in premenopausal women with HSDD.
Objective
To determine whether bremelanotide treatment in premenopausal women with HSDD provided clinically meaningful benefits.
Methods
Patients self-administered bremelanotide 1.75 mg or placebo using an autoinjector pen, as needed, for 24 weeks. Efficacy was assessed using these co-primary endpoints: change from baseline to end-of-study (EOS) for the Female Sexual Function Index–desire domain (FSFI-D) and Female Sexual Distress Scale–Desire/Arousal/Orgasm (FSDS-DAO) Item 13 scores. Clinically meaningful significance for the co-primary endpoints was evaluated using General Assessment Questionnaire Question 3 (GAQ Q3), a primary protocol-defined anchor that evaluated the patients’ perceived benefit of the drug (“Compared to the start of the study [prior to taking the study drug], to what degree do you think you benefitted from taking the study drug?”). GAQ Q3 scores ranged from 1 (very much worse) to 7 (very much better); responders were defined (based on input from a blinded independent anchor assessment committee) as score ≥5. Additionally, a cumulative distribution analysis was performed to determine the percentage of patients whose changes in the co-primary endpoints from baseline to EOS achieved predefined clinically meaningful thresholds (FSFI-D ≥0.6, FSDS-DAO Item 13 ≤-1). Finally, a receiver operating characteristics (ROC) analysis was performed to determine how predictive the co-primary endpoints were of the patient perceived benefit by measuring the area under the time-concentration curve (AUC). AUC=0.5 indicates no discrimination between a responder and nonresponder, while AUC >0.5 indicates discrimination between the two.
