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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: monophasic oral contraceptive (Drug); AZD7325 (Drug)

Phase: Phase 1

Status: Suspended

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Eleanor Lisbon, MD, MPH, Principal Investigator, Affiliation: Quintiles Phase I Services

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

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 AZD7325

To 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

Research Site, Overland Park, Kansas, United States
Additional Information

Starting date: May 2009
Last updated: December 8, 2010

Page last updated: August 23, 2015

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