Extract

Introduction

Hypoactive sexual desire disorder (HSDD) in women is characterized by a decrease or lack of sexual desire accompanied by distress. The investigational drug bremelanotide is a melanocortin-4-receptor agonist and analog of the endogenous neuropeptide α-melanocyte stimulating hormone. Two identically-designed, randomized, placebo-controlled, phase 3 studies - during which bremelanotide 1.75 mg or placebo was administered as desired via a subcutaneous autoinjector for 24 weeks - were conducted in accordance with FDA guidance on the development of drugs to treat female sexual dysfunction, including HSDD. Bremelanotide significantly increased sexual desire and reduced distress associated with desire compared to placebo. Patient experience data from participants in the RECONNECT phase 3 studies were also collected via an exit study, including a quantitative survey and qualitative interviews, to provide further insight into the perceived effects of treatment in the study and provide additional context for the clinical data.

Objective

To explore and report on the experience of the subset of participants from the RECONNECT phase 3 studies who participated in the qualitative interviews.

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