AZD6140 oral contraceptive interaction study
Study identifier:D5130C00042
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD6140, Levonorgestrel and Ethinyl Estradiol (Nordette®)
Sex
Female
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Apr 2008
Primary Completion Date: 01 Oct 2008
Study Completion Date: 01 Oct 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: AZD6140 90 mg tablet taken by mouth 2 times a day for 21 days per cycle |
| Active Comparator: 2 | Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) 1 tablet taken by mouth once a day for 28 days per cycle Other Name: Nordette® |
Contacts
Investigators
Principal Investigator
Kathleen Butler
AstraZeneca
