Source comparison
Top PT-141 Studies: Design Comparison
RECONNECT 301 Phase 3 650 premenopausal women with HSDD Change in monthly satisfying sexual events +0.9 SSEs/month +0.4 SSEs/month p<0.001 Statistically robust but clinically modest absolute benefit; translates to one additional satisfying event every 5–6 week
This comparison does not assign a generated winner or score.
- RECONNECT 301
- Phase 3
- 650 premenopausal women with HSDD
- Change in monthly satisfying sexual events
- +0.9 SSEs/month
- +0.4 SSEs/month
- p<0.001
- Statistically robust but clinically modest absolute benefit; translates to one additional satisfying event every 5–6 weeks
- RECONNECT 302
- 617 premenopausal women with HSDD
- +0.7 SSEs/month
- +0.3 SSEs/month
- p=0.002
- Reproduced RECONNECT 301 findings with slightly lower magnitude; consistency across trials strengthened FDA approval case
- Phase 2b (men with ED)
- Phase 2
- 271 men with erectile dysfunction
- Successful intercourse completion rate
- 52%
- 34%
- p<0.05
- Terminated before Phase 3 due to cardiovascular safety signals; male indication never pursued to approval
- Open-Label Extension
- Extension
- 498 women from RECONNECT trials
- Sustained efficacy over 52 weeks
- Maintained baseline improvements
- N/A
- Not assessed
- 35% discontinuation rate reveals real-world adherence challenges despite sustained statistical efficacy