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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)
Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01137708
A3921071

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Treatment Sequence 1
Experimental group
Treatment:
Drug: ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)
Treatment Sequence 2
Experimental group
Treatment:
Drug: CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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