Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder (Reconnect Study)

RECONNECT study evaluates bremelanotide (BMT) as a treatment for hypoactive sexual desire disorder (HSDD), characterized by a distressful lack of desire for sexual activity. Healthy premenopausal women with HSDD, ≥18 years, in a stable relationship. RECONNECT comprises two Phase 3 trials (301,302) consisting of a 4-week screening period, and a Core Phase (4-week at-home placebo, and 24-week randomized, double-blind treatment periods). Participants self-administered 1.75-mg BMT or placebo subcutaneously, as-desired, prior to sexual activity. Co-primary endpoints were Female Sexual Function Index: Desire Domain (FSFI-D) and Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Desire (item 13) scores. Secondary endpoints were change from baseline in FSFI total, arousal, lubrication, orgasm, and satisfaction scores; FSDS-DAO total and arousal item scores; Women’s Index of Treatment Satisfaction (WITS-9) score; self-assessment of benefit, and items from the Female Sexual Encounter Profile-Revised (FSEP-R), including satisfying sexual events (SSE). Mean age=39 years, and mean BMI=28.7 kg/m2 (n=1202). Both studies met co-primary endpoints. BMT significantly increased FSFI-D scores (301 mean change 0.69 vs 0.24; P<0.0001; 302: 0.80 vs 0.16; P<0.0001). For BMT, FSDS-DAO Desire scores showed a significant reduction in distress related to low desire (301 change -0.91 vs -0.34; P<0.0001; 302:-0.86 vs -0.38; P=0.0007). BMT was also associated with improvements in FSFI total, arousal, lubrication, orgasm, and satisfaction domain scores (all P≤0.01), FSDS-DAO total and arousal scores (both P≤0.01), and WITS-9 and self-assessed benefit (both P<0.0001). Number of SSEs were not significantly different from placebo; although BMT participants reported a higher percentage of sexual encounters as satisfactory. Most common discontinuations during double-blind phase were due to AEs (∼10%) and consent withdrawal (∼9%–12%).