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The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: ethinyl estradiol and levonorgestrel; exenatide (Drug); ethinyl estradiol and levonorgestrel; exenatide (Drug); ethinyl estradiol and levonorgestrel; exenatide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.

Clinical Details

Official title: The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

Secondary outcome:

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pre-menopausal female of child-bearing potential.

- Body Mass Index (BMI) between 19 and 35 kg/m^2, inclusive.

Exclusion Criteria:

- On implanted contraceptives for 6 months, or injectable contraceptives for 12 months

prior to the study.

- Evidence of diabetes mellitus.

- Participation in a study involving administration of an investigational compound

within the past 3 months.

Locations and Contacts

Research Site, Plymouth, United Kingdom
Additional Information

Starting date: November 2005
Last updated: August 17, 2015

Page last updated: August 23, 2015

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