PT-141 mastery course
Unit 5 of 11
The RECONNECT trials
The entire FDA approval rests on the RECONNECT program: two pre-specified, identically designed Phase 3 trials in preme…
What two Phase 3 trials actually showed, effect sizes and all
The entire FDA approval rests on the RECONNECT program: two pre-specified, identically designed Phase 3 trials in premenopausal women with HSDD. This is the strongest evidence PT-141 has, and it deserves an honest reading.
The unit walks the diagnostic target, the dose-finding that preceded it, the co-primary endpoints, and the two most important honesty points: the effect sizes are modest, and the satisfying-sexual-events endpoint did not separate from placebo.