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 CmaxSafety 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
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