Healthy
Conditions
Keywords
oral contraceptive, birth control, Healthy volunteers
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.
Interventions
DRUGAZD6140
90 mg tablet taken by mouth 2 times a day for 21 days per cycle
DRUGLevonorgestrel and Ethinyl Estradiol (Nordette®)
1 tablet taken by mouth once a day for 28 days per cycle
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette® | At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette® | At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. |
| Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette® | At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2. |
| Safety and tolerability of AZD6140 when co-administered with Nordette® | Screening through completion of the study |
Countries
United States
Outcome results
None listed