PT-141 Studied Low Libido: Trial Comparison
RECONNECT (N=1,247) Premenopausal women with generalized acquired HSDD Change in satisfying sexual events per month at 24 weeks +0.85 events/month +0.31 events/month p<0.001; nearly 3× improvement over placebo RECONNECT (co-primary) Same population Change in F
This comparison does not assign a generated winner or score.
- RECONNECT (N=1,247)
- Premenopausal women with generalized acquired HSDD
- Change in satisfying sexual events per month at 24 weeks
- +0.85 events/month
- +0.31 events/month
- p<0.001; nearly 3× improvement over placebo
- RECONNECT (co-primary)
- Same population
- Change in FSDS-DAO distress score at 24 weeks
- −14.0 points
- −10.4 points
- p<0.001; exceeded MCID threshold for clinically meaningful reduction in distress
- Phase 2b dose-ranging (N=327)
- Premenopausal women with HSDD
- Change in FSFI desire domain score at 12 weeks
- +0.7 points (1.75mg dose)
- +0.3 points
- p=0.002; established optimal dose for Phase 3
- Safety extension (N=580)
- RECONNECT completers continuing treatment
- Incidence of new adverse events during extended use (weeks 24–52)
- Nausea 18%, flushing 11%
- N/A (open-label extension)
- Lower incidence than initial 24 weeks, indicating tolerance development over time