AZD6140 Oral Contraceptive Interaction Study
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT00685906
- Run by
- AstraZeneca
- People needed
- 24
- Starts
- 2008-04-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2010-12-02
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Miami, Florida, United States
Full record on ClinicalTrials.gov
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