Official Title: “A Randomised, Double-Blind, Two-Way Crossover Study to Determine the Effects of Co-Administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers”

The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: AZD6140
  • 90 mg tablet taken by mouth 2 times a day for 21 days per cycle
• Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)
  • 1 tablet taken by mouth once a day for 28 days per cycle

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
  • Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
    Safety Issue?: No

Secondary Measures

• Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®
  • Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
    Safety Issue?: No
• Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®
  • Time Frame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.
    Safety Issue?: No
• Safety and tolerability of AZD6140 when co-administered with Nordette®
  • Time Frame: Screening through completion of the study
    Safety Issue?: No

Inclusion Criteria:

• Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
• Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take
• Nordette for 2 months prior to receiving the study drug
• Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide

Exclusion Criteria:

• History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
• History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
• History or presence of significant medical problems
• Women who are current smokers

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Kathleen Butler, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685906

Study ID Number: D5130C00042

ClinicalTrials.gov Identifier: NCT00685906

Health Authority: United States: Food and Drug Administration