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This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental |
| |
| Treatment Sequence 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN) | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN) | 12 days | |
| Number of adverse events and number of participants with adverse events | 12 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
|
| Changes in complete blood count and serum chemistry profile |
| 12 days |
| Changes in vital signs | 12 days |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D016912 | Levonorgestrel |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
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