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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01498861 | Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol | PHASE1 | COMPLETED | 16 | — | — | Dec 1, 2011 | Mar 1, 2012 | May 21, 2012 | 1 | United States |
Samples will be collected at predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 10 and 21
| Arm | Type | Description |
|---|---|---|
| Run-In Period | OTHER | Ortho-Cyclen for 21 days. Only for subjects who are not already taking Ortho-Cyclen prior to the study |
| Sequence AB | EXPERIMENTAL | Subjects will take Ortho-Cyclen once a day from Day 1-21 of their menstrual cycle. In addition they will take dolutegravir 50 mg twice a day from Days 1-10 and placebo twice a day from Day 12-21 |
| Sequence BA | EXPERIMENTAL | Subjects will take Ortho-Cyclen once a day from Day 1-21 of their menstrual cycle. In addition they will take placebo twice a day from Days 1-10 and dolutegravir 50 mg twice a day from Day 12-21 |
| Name | Type | Description |
|---|---|---|
| Ortho-Cyclen | DRUG | Ortho-cyclen is an oral contraceptive. |
| Dolutegravir | DRUG | Dolutegravir is an experimental HIV drug |
| Placebo | DRUG | Placebo is a tablet with no drug in it |
Inclusion Criteria: * Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN) * Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, p...