CP-690,550 And Oral Contraception Drug-Drug Interaction Study
A Phase 1, Randomized, Open Label, 2-Way Crossover Study To Assess The Effect Of Multiple Dose CP-690,550 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids In Healthy Female Subjects
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jun 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedAugust 6, 2010
August 1, 2010
1 month
May 14, 2010
August 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
12 days
Secondary Outcomes (4)
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
Study Arms (2)
Treatment Sequence 1
EXPERIMENTALTreatment Sequence 2
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- Healthy female subjects
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2010
First Posted
June 4, 2010
Study Start
June 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
August 6, 2010
Record last verified: 2010-08