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Clinical evidence RECONNECT trials: The FDA approval was based on two Phase 3 trials involving over 1,200 premenopausal women with HSDD: Significant increases in Female Sexual Function Index-desire domain scores Reduced distress related to low sexual desire Benefits maintained through 52-week open-label extension Rapid improvement when placebo patients switched to active treatment Earlier research: A 2006 study in premenopausal women with sexual arousal disorder found significantly more women reported moderate or high sexual desire after PT-141 compared to placebo (p=0.0114)

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10.1016/j.chest.2018.02.025 Chest 42 DoskeyC