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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01458210 | A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants | PHASE1 | COMPLETED | 22 | — | — | Oct 1, 2011 | Feb 1, 2012 | Oct 8, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Ortho-Cyclen (OC) Alone (Period 1); OC+Dulaglutide (Period 2) | EXPERIMENTAL | Ortho-Cyclen (OC) (0.25 milligram \[mg\] norelgestromin \[NGMN\] + 0.035 mg ethinyl estradiol \[EE\] \[active tablets\] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course and the Period 2 sample was taken during the second 28-day course. Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2. |
| Name | Type | Description |
|---|---|---|
| Ortho-Cyclen | DRUG | Administered orally |
| Dulaglutide | BIOLOGICAL | Administered subcutaneously |
Inclusion Criteria: * Are females of child-bearing potential, and who are overtly healthy as determined by medical history and physical examination * As it is possible that dulaglutide may cause the oral contraceptive (OC) tablet to be less effective than usual, participants will be required to ...