Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DR-104 · 1 trial · 1 indication
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...
DR-104 is an investigational small molecule being developed for emergency contraception. It is intended for use as an emergency contraceptive to prevent pregnancy after unprotected intercourse or contraceptive failure.
DR-104 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical development of this investigational emergency contraceptive.
DR-104 is in Phase 3 clinical development. It has completed one Phase 3 trial, and it remains an investigational drug that has not been approved by regulatory authorities.
DR-104 has one completed Phase 3 clinical trial, NCT00777556, titled "Emergency Contraception Actual Use Study." This study enrolled 343 female participants aged 11 years and older in the United States and evaluated the drug in a real-world setting.
No alternative names for DR-104 have been disclosed. It is identified solely by its developmental code DR-104 in clinical trial records and by the developer.