Bremelanotide, an investigational new drug, demonstrated efficacy in premenopausal women with hypoactive sexual desire disorder (HSDD) in the RECONNECT studies. In this analysis, bremelanotide efficacy was investigated across hormonal contraceptive subgroups.
RECONNECT comprised two replicate, phase 3, double-blind, randomized, placebo-controlled, IRB-approved studies. Subjects self-administered bremelanotide 1.75 mg or placebo subcutaneously for 24 weeks, using an autoinjector pen on demand prior to sexual activity. Subjects were evaluated (“yes” and “no” subgroups) based on concurrent use of hormonal contraceptives (including oral contraceptives and other estrogen-containing products). Efficacy was assessed using RECONNECT co-primary endpoints: change from baseline to end-of-study (EOS) for Female Sexual Function Index-desire domain (FSFI-D) and Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Item 13 scores.
In the integrated population (N=1202), difference in mean change in FSFI-D and FSDS-DAO Item 13 from baseline to EOS (bremelanotide-placebo) was 0.35 and -0.33, respectively (P<.0001 for both endpoints). In the study, 18.4% (N=221) concurrently used hormonal contraceptives (“yes” subgroup). Subjects in "no" subgroup who were treated with bremelanotide (N=484) showed a statistically significant increase in FSFI-D relative to placebo (N=497; 0.39, P<.0001). Those in "yes" subgroup showed a numerical difference in favor of bremelanotide (N=112) versus placebo (N=109; 0.19, P=.1557). Change from baseline to EOS in FSDS-DAO Item 13 was statistically significant in favor of bremelanotide relative to placebo in both subgroups (-0.30 and -0.34; P=.0471 and P<.0001, respectively).
Independent of the type of contraceptive used, bremelanotide demonstrated improvements in sexual desire and related distress in premenopausal women with HSDD.