The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00254800
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
- Pre-menopausal female of child-bearing potential.
- Body Mass Index (BMI) between 19 and 35 kg/m^2, inclusive.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 3 ethinyl estradiol and levonorgestrel; exenatide Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide Sequence 2 ethinyl estradiol and levonorgestrel; exenatide Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide Sequence 1 ethinyl estradiol and levonorgestrel; exenatide Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone
- Primary Outcome Measures
Name Time Method Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax 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 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.
- Secondary Outcome Measures
Name Time Method Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax 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 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.
Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies. Baseline through Day 84 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.
Trial Locations
- Locations (1)
Research Site
🇬🇧Plymouth, United Kingdom