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ethinyloestradiol and levonorgestrel, CP-690, 550+ ethinyloestradiol and levonorgestrel · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | - |
| Treatment Sequence 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN) | DRUG | Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID |
| CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN) | DRUG | Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone |
Inclusion Criteria: * Healthy female subjects * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis Exclusion Criteria: * Any medical reason which would contraindicate the administration of oral contraceptives * Clinically significant infections withi...
It is a combination of ethinyloestradiol and levonorgestrel, an oral contraceptive, studied together with CP-690,550 in a Phase 1 drug-drug interaction trial. The study enrolled healthy female volunteers to assess how the two agents interact when given together. It is not a standalone product but a study combination.
Pfizer, Inc. (ticker: PFE) is the developer of this combination. The company sponsored the Phase 1 drug-drug interaction study evaluating CP-690,550 with ethinyloestradiol and levonorgestrel. Pfizer holds the investigational asset.
It is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study was a controlled, randomized Phase 1 drug-drug interaction trial in healthy female volunteers.
The combination was evaluated in one completed Phase 1 trial, NCT01137708, titled "CP-690,550 And Oral Contraception Drug-Drug Interaction Study." It enrolled 20 healthy female volunteers aged 18 years and older in Belgium. The trial was randomized, controlled, and did not use double blinding.