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Ortho-Cyclen · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Ortho-Cyclen | EXPERIMENTAL | Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods. Treatment A |
| Ortho-Cyclen + Evacetrapib | EXPERIMENTAL | Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods. Treatment B |
| 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 | Oral administration |
| Evacetrapib | DRUG | Oral administration |
| Dulaglutide | BIOLOGICAL | Administered subcutaneously |
Inclusion Criteria: * Are pre-menopausal females, and who are healthy as determined by medical history and physical examination * Have a body mass index of 18 to 30 kilograms per square meter (kg/m\^2) Exclusion Criteria: * Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol a...
Ortho-Cyclen is an oral contraceptive studied in healthy female participants. It has been evaluated in clinical trials for its effects on how the body handles other drugs, including in the context of diabetes mellitus type 2 and healthy volunteers. It is not approved for any indication.
Ortho-Cyclen is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The company has conducted clinical trials involving this drug in the United States.
Ortho-Cyclen is in Phase 1 clinical development. It has been studied in early-stage trials, with one completed trial involving healthy female participants. The drug remains investigational and has not been approved by regulatory authorities.
Ortho-Cyclen has been involved in two completed Phase 1 trials. NCT01458210 studied its effect on how the body handles dulaglutide in healthy female participants with type 2 diabetes. NCT01746732 studied evacetrapib in healthy female participants. Both trials were conducted in the United States.
No, Ortho-Cyclen is not the same as dulaglutide or evacetrapib. It was used as an oral contraceptive in drug interaction studies to assess how these investigational drugs affect the body's handling of oral contraceptives. Each is a distinct drug product.
Ortho-Cyclen is an oral contraceptive, but its specific molecular target is not disclosed in the available clinical trial information. It is used in studies to evaluate potential drug interactions with other investigational medications in healthy female participants.