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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00777556 | Emergency Contraception Actual Use Study | PHASE3 | COMPLETED | 343 | — | — | Oct 1, 2008 | Dec 1, 2010 | Oct 18, 2012 | 5 | United States |
The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.
The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.
| Arm | Type | Description |
|---|---|---|
| DR-104 | EXPERIMENTAL | One tablet for emergency contraception |
| Name | Type | Description |
|---|---|---|
| DR-104 | DRUG | One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse. |
Inclusion Criteria: * Female and 11-16 years of age, inclusive * Subject must be requesting emergency contraception for her own use (not for use by another person) and for current (not future) use * Subject can read and understand English, according to her own judgment * Others as dictated by FDA-a...