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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01137708

Enrollment

Registered

2010-06-04

Start date

2010-06-30

Completion date

2010-07-31

Last updated

2010-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

drug interactions, CYP3A, oral contraceptive, anti-rheumatic agents

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.

Interventions

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

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

DRUGCP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)	12 days

Secondary

Measure	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
Changes in complete blood count and serum chemistry profile	12 days
Changes in vital signs	12 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026