The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

AstraZeneca38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

ethinyl estradiol and levonorgestrel; exenatideDRUG

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; exenatideDRUG

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; exenatideDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Plymouth, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: Baseline through Day 84

Data from ClinicalTrials.gov

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