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A. Clayton, J. Simon, S. Kingsberg, R. Jordan, J. Lucas, L. Williams, J. Krop, 029 Bremelanotide for Hypoactive Sexual Desire Disorders in the RECONNECT Studies: Analysis of Baseline Free Testosterone Level Quartile Subgroups, The Journal of Sexual Medicine, Volume 16, Issue Supplement_3, June 2019, Pages S13–S14, https://doi.org/10.1016/j.jsxm.2019.03.486
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Introduction
Hypoactive sexual desire disorder (HSDD) is the most prevalent form of female sexual dysfunction in the United States, and is characterized by a decrease or lack of sexual desire accompanied by distress. Bremelanotide, a melanocortin-4-receptor (MC4R) agonist and an analog of the endogenous neuropeptide α-melanocyte stimulating hormone, is an investigational drug that is currently being evaluated in premenopausal women with HSDD. The RECONNECT studies, which comprised two replicate, phase 3 clinical trials, demonstrated that subcutaneous self-administration of bremelanotide significantly improved sexual desire and decreased personal distress in premenopausal women with HSDD.
Objective
To assess the efficacy of bremelanotide across baseline free testosterone level quartile subgroups.
Methods
The RECONNECT studies comprised two replicate studies with a 24-week, randomized, double-blind, placebo-controlled core study phase and an optional 52-week open-label safety extension phase. Participants self-administered bremelanotide 1.75 mg or placebo subcutaneously using an autoinjector, on demand, prior to sexual activity. A total of 1202 subjects were included in the integrated and subgroup analyses. Subjects were divided into subgroups according to free (bioavailable) testosterone level at screening. Free testosterone levels were calculated using baseline total testosterone, sex hormone-binding globulin (SHBG), and albumin levels. For the subgroup analysis, subjects with total testosterone levels >96 ng/dL or SHBG levels >170 nmol/L at screening were excluded, as those were above the normal physiological range. Efficacy was assessed using the co-primary endpoints of change from baseline to the end-of-study (EOS) for the Female Sexual Function Index-Desire domain (FSFI-D) and the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Item 13 scores.
