PT-141 Long Term Studies: Comparison Across Trial Designs
RECONNECT (Phase 3) 24 weeks 1,247 premenopausal women with HSDD 1.75mg SC as-needed Change in desire domain score (FSFI) 4.8% No decline in efficacy from week 8 to week 24; nausea resolved by week 8 in 82% of participants Phase 2b Dose-Ranging 327 premenopaus
This comparison does not assign a generated winner or score.
- RECONNECT (Phase 3)
- 24 weeks
- 1,247 premenopausal women with HSDD
- 1.75mg SC as-needed
- Change in desire domain score (FSFI)
- 4.8%
- No decline in efficacy from week 8 to week 24; nausea resolved by week 8 in 82% of participants
- Phase 2b Dose-Ranging
- 327 premenopausal women
- 0.75mg, 1.25mg, 1.75mg SC
- FSFI total score improvement
- 6.2%
- Dose-response relationship sustained across trial; higher doses showed no increase in discontinuation after titration
- Open-Label Extension
- 52 weeks
- 298 women (rollover from Phase 3)
- 1.75mg SC
- Safety monitoring only
- 9.1%
- Blood pressure effects remained transient; no cumulative cardiovascular changes; adverse events stable after week 12