Summary

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• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• Bremelanotide Effectiveness: Bremelanotide significantly improved sexual desire, with increases reported as 0.30, 0.42, and 0.35, alongside a decrease in distress related to low sexual desire (-0.37, -0.29, and -0.33) across multiple subgroups, including age, weight, body mass index (BMI), hormonal contraceptive use, and hypoactive sexual desire disorder (HSDD) duration.
• Subgroup Consistency: Significant improvements in sexual desire and distress were observed regardless of hormonal contraceptive use, decreased arousal, or HSDD duration, indicating broad efficacy across various demographics, including a predominantly white population (85.6%) with a mean age of 39 years.
• Safety Profile Context: The studies focused on premenopausal women with hypoactive sexual desire disorder, and while specific safety outcomes for different subgroups were not detailed, the overall safety profile indicated mild to moderate adverse events, predominantly nausea, which was the primary reason for discontinuation.
• Adverse Events Profile: Bremelanotide was associated with common adverse events, including nausea (40.0% vs. 1.3% in placebo), flushing (20.3% vs. 1.3% in placebo), headache (11.3% vs. 1.9% in placebo), and injection site reactions (5.4% vs. 0.5% in placebo). Nausea was the most common reason for discontinuation of the drug.
• Safety Concerns: Although no deaths were reported, caution is advised for patients at risk of cardiovascular disease due to small, transient, but statistically significant increases in blood pressure. Focal hyperpigmentation occurred in over one-third of subjects receiving up to 16 consecutive daily doses.
• Bremelanotide demonstrated significant improvements in sexual desire and decreased distress associated with low sexual desire across various subgroups, including age, weight, BMI, and bioavailable testosterone levels. Improvements were consistent regardless of hormonal contraceptive use, presence of decreased arousal, or duration of HSDD. The population predominantly consisted of white participants (85.6%) with a mean age of 39 years.