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

AstraZeneca

Status and phase: Suspended; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: monophasic oral contraceptive; Drug: AZD7325

Study type: Interventional

Funder types: Industry

Identifiers

NCT00901290

D1140C00018

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

56 participants in 2 patient groups

1

Experimental group

Description:

monophasic oral contraceptive

Treatment:

Drug: monophasic oral contraceptive

2

Experimental group

Description:

AZD7325

Treatment:

Drug: AZD7325