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Clinical Trial Details

Trial ID: L5940
Source ID: NCT00254800
Associated Drug: Ethinyl Estradiol And Levonorgestrel; Exenatide
Title: The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ethinyl estradiol and levonorgestrel; exenatide|DRUG: ethinyl estradiol and levonorgestrel; exenatide|DRUG: ethinyl estradiol and levonorgestrel; exenatide
Outcome Measures: Primary: Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax, To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose., Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48 | Secondary: Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax, To evaluate the effect of exenatide on the single-dose pharmacokinetics of the combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose., Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48|Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies., Assessment of the safety and tolerability of concomitant administration of exenatide and the combination oral contraceptive by incidence of adverse events, Adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram (ECG), blood glucose, body weight, physical examination and exenatide antibodies., Baseline through Day 84
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: FEMALE
Age: ADULT
Phases: PHASE1
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-11
Completion Date: 2006-08
Results First Posted:
Last Update Posted: 2015-08-18
Locations: Research Site, Plymouth, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00254800