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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00254800 | The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females | PHASE1 | COMPLETED | 38 | — | — | Nov 1, 2005 | Aug 1, 2006 | Aug 18, 2015 | 1 | United Kingdom |
To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone |
| Sequence 2 | EXPERIMENTAL | Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide |
| Sequence 3 | EXPERIMENTAL | Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide |
| Name | Type | Description |
|---|---|---|
| ethinyl estradiol and levonorgestrel; exenatide | DRUG | Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily |
Inclusion Criteria: * Pre-menopausal female of child-bearing potential. * Body Mass Index (BMI) between 19 and 35 kg/m\^2, inclusive. Exclusion Criteria: * On implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study. * Evidence of diabetes mellitus. * P...