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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00551616 | Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception | PHASE3 | COMPLETED | 2,221 | — | — | Apr 1, 2007 | Apr 1, 2009 | May 3, 2022 | 33 | United States, Ireland +1 |
| NCT01107093 | Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge | PHASE2 | COMPLETED | 35 | — | — | May 1, 2008 | Dec 1, 2008 | Aug 25, 2010 | 2 | Chile, Dominican Republic |
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment
| Arm | Type | Description |
|---|---|---|
| CDB-2914 | EXPERIMENTAL | - |
| Levonorgestrel | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CDB-2914 | DRUG | Single dose |
| Levonorgestrel | DRUG | Single dose |
| CDB-2914 (ulipristal acetate) | DRUG | single oral dose of 30 mg |
| Placebo | DRUG | single oral dose |
Inclusion Criteria: * women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US * present within 120 hours of unprotected intercourse * regular menstrual cycles * No current use of hormonal contraception * Willing to not...