Status:
COMPLETED
AZD6140 Oral Contraceptive Interaction Study
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00685906
Start Date
April 1 2008
End Date
October 1 2008
Last Update
December 2 2010
Active Locations (1)
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1
Research Site
Miami, Florida, United States