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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00394771 | A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale | PHASE2 | COMPLETED | 567 | — | — | Oct 1, 2006 | Mar 1, 2008 | Jul 26, 2013 | 50 | United States |
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
| Arm | Type | Description |
|---|---|---|
| Low Dose DR-1031 | EXPERIMENTAL | 42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. |
| Midrange Dose DR-1031 | EXPERIMENTAL | 21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. |
| High Dose DR-1031 | EXPERIMENTAL | 21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. |
| Seasonale | ACTIVE_COMPARATOR | 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets. |
| Name | Type | Description |
|---|---|---|
| DR-1031 | DRUG | Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm. |
| Seasonale® | DRUG | 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles. |
| Portia® | DRUG | Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication. |
Inclusion Criteria: * Premenopausal * Not pregnant or breastfeeding * Agree to use back-up non-hormonal contraception for study period Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \>10 cigarettes per day