PT-141 HSDD Research Mechanism: Study Comparison
RECONNECT I (2019) 580 premenopausal women with acquired HSDD 24 weeks Change in FSFI desire domain + FSDS-DAO distress score 25.0% 17.0% 12.5 Nausea (40% vs 13%) Statistically significant but modest benefit; high discontinuation due to GI side effects RECONNE
This comparison does not assign a generated winner or score.
- RECONNECT I (2019)
- 580 premenopausal women with acquired HSDD
- 24 weeks
- Change in FSFI desire domain + FSDS-DAO distress score
- 25.0%
- 17.0%
- 12.5
- Nausea (40% vs 13%)
- Statistically significant but modest benefit; high discontinuation due to GI side effects
- RECONNECT II (2019)
- 687 premenopausal women with acquired HSDD
- 24.8%
- 17.4%
- 13.5
- Nausea (41% vs 12%)
- Replicated RECONNECT I findings; cardiovascular monitoring required due to transient BP elevation
- Open-Label Extension (2020)
- Subset of RECONNECT participants
- 52 weeks
- Safety and sustained efficacy
- Stable response over 52 weeks; no tachyphylaxis observed
- N/A
- Nausea (diminished over time in continuing users)
- Long-term use appears safe in responders, but predictive biomarkers for response remain absent