Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 Pfizer's investigational drug CP-690,550 in a Phase 1 drug-drug interaction trial. The study enrolled 20 healthy female volunteers in Belgium to assess how the two agents interact when given together.
Pfizer, Inc. (ticker PFE) is the developer associated with this combination. The company sponsored the Phase 1 drug-drug interaction study evaluating CP-690,550 co-administered with ethinyloestradiol and levonorgestrel.
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 conducted 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 and controlled but not double-blind.