The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
Study identifier:H8O-EW-GWBC
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ethinyl estradiol and levonorgestrel; exenatide
Sex
Female
Actual Enrollment
38
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Nov 2005
Primary Completion Date: 01 Aug 2006
Study Completion Date: 01 Aug 2006
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Eli Lilly and Company
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence 1 Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone | Drug: ethinyl estradiol and levonorgestrel; exenatide Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily Other Name: Byetta Other Name: AC2993 |
| Experimental: Sequence 2 Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide | Drug: ethinyl estradiol and levonorgestrel; exenatide Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily Other Name: Byetta Other Name: AC2993 |
| Experimental: Sequence 3 Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide | Drug: ethinyl estradiol and levonorgestrel; exenatide Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily Other Name: Byetta Other Name: AC2993 |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Company
