The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254800
• Other study ID #: H8O-EW-GWBC
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2005
• Last updated: August 17, 2015
• Start date: November 2005
• Est. completion date: August 2006

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	Research Site	Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Yes
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	Yes
Secondary	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	No