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

AstraZeneca56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Pharmacokinetics

Interventions

monophasic oral contraceptiveDRUG

mg, oral dose

AZD7325DRUG

mg, oral dose

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN

Time frame: weekly

Secondary Outcomes

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

Time frame: weekly

To characterize the steady-state pharmacokinetics of AZD7325

Time frame: weekly

To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)

Time frame: weekly

Data from ClinicalTrials.gov

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