Status:
SUSPENDED
Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Pharmacokinetics
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive
Eligibility Criteria
Inclusion
- If previously pregnant, must be \> 6 month post-partum at the time of randomization
- Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2
Exclusion
- Use of any prescription medication within 14 days of screening
- current smoker or history of smoking within the last 3 months prior to enrollment
- Abnormal pap smear exam result within one year of enrollment.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00901290
Start Date
May 1 2009
End Date
September 1 2009
Last Update
December 10 2010
Active Locations (1)
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1
Research Site
Overland Park, Kansas, United States