Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05139121 | Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles | PHASE3 | COMPLETED | 1,319 | — | — | Oct 26, 2021 | Jan 15, 2025 | Jan 28, 2025 | 100 | United States, Canada +1 |
The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years times 100
| Arm | Type | Description |
|---|---|---|
| MR-100A-01 | EXPERIMENTAL | MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol |
| Name | Type | Description |
|---|---|---|
| MR-100A-01 | DRUG | Transdermal contraceptive delivery system |
Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age with no upper age limit. Post-menarcheal female subjects who are at risk of pregnancy, and \<18 years are eligible provided that: 1. Applicable national, state, and loca...