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NCT Number: NCT00254800

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Plymouth, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ethinyl estradiol and levonorgestrel; exenatide

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

Other names: Byetta, AC2993

Primary outcomes

  1. Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

    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

    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 outcomes

  1. Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

    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

    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.

  2. Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 17, 2005
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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