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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01252186 | A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women | PHASE2 | COMPLETED | 265 | — | — | Nov 1, 2010 | Dec 1, 2011 | Mar 13, 2015 | 24 | United States, Italy |
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.
| Arm | Type | Description |
|---|---|---|
| 91-day Levonorgestrel Oral Contraceptive | EXPERIMENTAL | Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. |
| 28-day Levonorgestrel Oral Contraceptive | ACTIVE_COMPARATOR | Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
| 28-day Desogestrel Oral Contraceptive | ACTIVE_COMPARATOR | Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| 91-day Levonorgestrel Oral Contraceptive | DRUG | 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. |
| 28-day Levonorgestrel Oral Contraceptive | DRUG | 21 combination tablets containing 150 µg LNG/30 µg EE. |
| 28-day Desogestrel Oral Contraceptive | DRUG | 21 combination tablets containing 150 µg DSG/30 µg EE. |
Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating women age 18-40 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by FDA-approved protocol Exclusion Criteria: * Any condition which contraindicates the use of comb...