CP-690,550 And Oral Contraception Drug-Drug Interaction Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN); Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)

• Registration Number: NCT01137708
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-14
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 within the past 3 months or history of febrile illness within 5 days
• Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
• Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 2	CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)	-
Treatment Sequence 1	ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)	-

Primary Outcome Measures

Name	Time	Method
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)	12 days

Secondary Outcome Measures

Name	Time	Method
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
Changes in complete blood count and serum chemistry profile	12 days
Changes in vital signs	12 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium