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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01137708
First received: May 14, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Healthy
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)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN) [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN) [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Number of adverse events and number of participants with adverse events [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
  • Changes in complete blood count and serum chemistry profile [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
  • Changes in vital signs [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence 1 Drug: ethinyloestradiol (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
Experimental: Treatment Sequence 2 Drug: CP-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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137708

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01137708     History of Changes
Other Study ID Numbers: A3921071
Study First Received: May 14, 2010
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
drug interactions
CYP3A
oral contraceptive
anti-rheumatic agents

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Tofacitinib
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014