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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00544882 | A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021 | PHASE3 | COMPLETED | 61 | — | — | Oct 31, 2007 | Mar 31, 2008 | Nov 18, 2021 | 4 | United States |
Levels of estradiol were measured throughout the study from blood samples.
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Levels of inhibin-B were measured throughout the study from blood samples.
| Arm | Type | Description |
|---|---|---|
| DR-1021 | EXPERIMENTAL | After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Mircette | ACTIVE_COMPARATOR | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Name | Type | Description |
|---|---|---|
| DR-1021 | DRUG | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets. |
| Mircette® | DRUG | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. |
| Kariva® | DRUG | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. |
Inclusion Criteria: * Premenopausal * Weight \<200 lbs * Currently taking or willing to be treated with an oral contraceptive with a standard 21/7 regimen for one cycle prior to starting Study Cycle 1 * Others as dictated by protocol Exclusion Criteria: * Any contraindication to the use of oral c...