NCT00254800

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2005

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

November 15, 2005

Last Update Submit

August 17, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesexenatideAmylinLilly

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Sequence 1

EXPERIMENTAL

Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone

Drug: ethinyl estradiol and levonorgestrel; exenatide

Sequence 2

EXPERIMENTAL

Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

Sequence 3

EXPERIMENTAL

Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide

Drug: ethinyl estradiol and levonorgestrel; exenatide

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

Also known as: Byetta, AC2993
Sequence 1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pre-menopausal female of child-bearing potential.
  • Body Mass Index (BMI) between 19 and 35 kg/m\^2, inclusive.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Plymouth, United Kingdom

Location

Related Publications (1)

  • Kothare PA, Seger ME, Northrup J, Mace K, Mitchell MI, Linnebjerg H. Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial. BMC Clin Pharmacol. 2012 Mar 19;12:8. doi: 10.1186/1472-6904-12-8.

    PMID: 22429273DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Ethinyl EstradiolLevonorgestrelExenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorgestrelNorpregnenesPeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • James Malone, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

November 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

GB(1)