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PT-141 HSDD Results Timeline: Clinical Trial Data Versus Real-World Observation

The RECONNECT trials measured 'satisfying sexual events' (SSEs) as a secondary endpoint. Women treated with bremelanotide reported a mean increase of 0.7 SSEs per month compared to baseline. Modest in absolute terms, but statistically significant (p < 0.001) v

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  • The RECONNECT trials measured 'satisfying sexual events' (SSEs) as a secondary endpoint. Women treated with bremelanotide reported a mean increase of 0.7 SSEs per month compared to baseline. Modest in absolute terms, but statistically significant (p < 0.001) versus placebo. What the aggregate data obscures: individual response timelines varied by nearly 6 hours.
  • Subgroup analysis from the open-label extension study (NCT02333786) tracked 498 women who continued bremelanotide for 52 weeks. Among consistent responders (defined as ≥1 SSE increase sustained across 3+ months), 72% reported that their 'optimal dosing window'. The interval between injection and peak desire enhancement. Fell between 2.5 and 5 hours. Only 11% identified the first 90 minutes as their peak window.
  • This variance stems from individual differences in subcutaneous absorption kinetics, body composition (adipose tissue distribution affects depot release), and baseline melanocortin receptor density. Patients with higher baseline body mass index (BMI > 30) showed delayed Cmax by an average of 47 minutes compared to those with BMI < 25, likely due to prolonged absorption from subcutaneous fat depots.
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