Trial | NCT00685906  Report issue

Title

AZD6140 Oral Contraceptive Interaction Study
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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 Started
Apr 30
2008
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Dec 02
2010
Estimate

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

  • Other names: Nordette®

1 Experimental

2 Active Comparator

Criteria 

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
No Results Posted