Pharmacokinetics
Conditions
Keywords
oral contraceptive
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
Interventions
DRUGmonophasic oral contraceptive
mg, oral dose
DRUGAZD7325
mg, oral dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN | weekly |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325 | weekly |
| To characterize the steady-state pharmacokinetics of AZD7325 | weekly |
| To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN) | weekly |
Countries
United States
Outcome results
None listed