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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00196365 | A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain | PHASE3 | COMPLETED | 97 | — | — | Jan 1, 2005 | Jul 1, 2007 | May 12, 2014 | 18 | United States |
| NCT00196313 | A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain | PHASE2 | COMPLETED | 95 | — | — | May 1, 2005 | Oct 1, 2008 | Sep 22, 2016 | 13 | United States |
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| 1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets | DRUG | 1 tablet daily |
| levonorgestrel/EE 0.15/0.03 mg tablets and placebo | DRUG | 1 tablet daily |
| Placebo tablet | DRUG | 1 tablet daily by mouth |
Inclusion Criteria: * Moderate to severe menstrual-related pain * Regular spontaneous menstrual cycles Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Treatment with an oral contraceptive in the last 3 months * Previous treatment failure with an extended oral contra...