Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects
Phase 1
Suspended
- Conditions
- Pharmacokinetics
- Interventions
- Drug: monophasic oral contraceptive
- Registration Number
- NCT00901290
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 56
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 monophasic oral contraceptive monophasic oral contraceptive 2 AZD7325 AZD7325
- Primary Outcome Measures
Name Time Method To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN weekly
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Overland Park, Kansas, United States