Determine the Effects of c-Administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: monophasic oral contraceptive (Drug); AZD7325 (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Eleanor Lisbon, MD, MPH, Principal Investigator, Affiliation: Quintiles Phase I Services
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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
Clinical Details
Official title: A Randomized, Open-Label, Two-Way Crossover Study to Determine the Effects of Co-Administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Study design: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Primary outcome: To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN
Secondary outcome: 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 AZD7325To characterize the steady-state pharmacokinetics of AZD7325 To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Overland Park, Kansas, United States; Recruiting
Additional Information
Starting date: May 2009
Ending date: November 2009
Last updated: May 13, 2009
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