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NCT00901290 Clinical Trial

Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00901290
Other study ID # D1140C00018
Secondary ID
Status Suspended
Phase Phase 1
First received May 12, 2009
Last updated December 8, 2010
Start date May 2009
Est. completion date September 2009

Study information
Verified date October 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Suspended
Enrollment 56
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• monophasic oral contraceptive
mg, oral dose
• AZD7325
mg, oral dose

Locations
Country Name City State
United States Research Site Overland Park Kansas

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN weekly No
Secondary 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 No
Secondary To characterize the steady-state pharmacokinetics of AZD7325 weekly No
Secondary To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN) weekly Yes
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