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

NCT ID: NCT00901290

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Pharmacokinetics

Keywords

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oral contraceptive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

monophasic oral contraceptive

Group Type EXPERIMENTAL

monophasic oral contraceptive

Intervention Type DRUG

mg, oral dose

2

AZD7325

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

mg, oral dose

Interventions

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monophasic oral contraceptive

mg, oral dose

Intervention Type DRUG

AZD7325

mg, oral dose

Intervention Type DRUG

Other Intervention Names

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ORTHO-CYCLEN

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Eleanor Lisbon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase I Services

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D1140C00018

Identifier Type: -

Identifier Source: org_study_id