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P. Koochaki, D. Revicki, H. Wilson, R. Pokrzywinski, R. Jordan, J. Lucas, 080 Women’s Experiences With Bremelanotide Administered, On Demand, for the Treatment of Hypoactive Sexual Desire Disorder, The Journal of Sexual Medicine, Volume 16, Issue Supplement_3, June 2019, Page S30, https://doi.org/10.1016/j.jsxm.2019.03.521
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Introduction
Hypoactive sexual desire disorder (HSDD) is characterized by a decrease or lack of sexual desire accompanied by distress, and affects 8.9% of women aged 18-44 years in the United States. Bremelanotide, an investigational new drug, is a melanocortin-4-receptor (MC4R) agonist and analog of the endogenous neuropeptide α-melanocyte stimulating hormone. In RECONNECT, which consisted of two replicate, placebo-controlled phase 3 studies, bremelanotide demonstrated statistically significant and clinically meaningful improvements in low sexual desire and related distress in premenopausal women with HSDD. Here, outcomes from the RECONNECT studies are presented with a focus on the patients’ perspective of treatment benefits.
Objective
To provide a deeper understanding of the effect of bremelanotide and the meaningfulness of treatment benefits beyond the clinical trial Results.
Methods
RECONNECT 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. At the end of the double-blind treatment period, 242 subjects participated in quantitative exit surveys; of those subjects, 80 completed qualitative interviews. From the 80 subjects, 35 (44%) were randomized to bremelanotide and 45 (56%) were randomized to placebo. Results from both the quantitative surveys and qualitative interviews are reported.
