Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ortho-Cyclen · 1 trial · 1 indication
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...
Ortho-Cyclen is a small molecule being studied for use in Human Immunodeficiency Virus (HIV) infection. It is an oral contraceptive containing norgestimate and ethinylestradiol, and in the context of this research it is being evaluated for potential drug interactions in HIV treatment. It is currently in Phase 1 clinical development.
Ortho-Cyclen is developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting research on this drug in the therapeutic area of infectious disease, specifically for HIV infection.
Ortho-Cyclen is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. There is one completed Phase 1 trial involving this drug, and it is not currently in active clinical trials.
Ortho-Cyclen has one completed clinical trial, identified as NCT01498861. This was a Phase 1 drug interaction study between dolutegravir and an oral contraceptive containing norgestimate and ethinylestradiol. The trial enrolled 16 female participants in the United States and included healthy volunteers.
Yes, Ortho-Cyclen is an oral contraceptive that contains norgestimate and ethinylestradiol. In the clinical trial NCT01498861, it was studied for potential interactions with dolutegravir, an HIV medication. The study was conducted in healthy female volunteers to assess safety and drug interactions.