The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

NCT00254800 · Completed

Last updated 2026-05-28

This clinical trial tested how the diabetes medication exenatide affects the levels of birth control pills in the bloodstream of healthy women.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 38 people

Who can join Ages 18–45 · female only Healthy volunteers accepted.

Timeline Started 2005-11 · est. completion 2006-08

Where 1 site · United Kingdom

What this study is testing ClinicalTrials.gov NCT00254800 ↗

Description as written by the study sponsor.

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

ethinyl estradiol and levonorgestrel; exenatide also known as Byetta, AC2993 Drug

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 also known as Byetta, AC2993 Drug

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 also known as Byetta, AC2993 Drug

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

Main thing measured	Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00254800 ↗