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Trial · Interventional

CompletedPhase 1Registry data

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

NCTNCT00254800 (opens ClinicalTrials.gov in a new tab)Other idH8O-EW-GWBC
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Overview

Status
Completed
Phase
Phase 1
Enrollment
38 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Nov 2005
Primary completion
Aug 2006
Completion
Aug 2006
First posted
17 Nov 2005 (estimated)
Last update posted
18 Aug 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007
  1. Ph 1

    The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

    NCT00254800

    Nov 2005 to Aug 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ethinyl estradiol and levonorgestrel; exenatideDrug
  • ethinyl estradiol and levonorgestrel; exenatideDrug
  • ethinyl estradiol and levonorgestrel; exenatideDrug

Arms3

  • Experimental

    Sequence 1

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

  • Experimental

    Sequence 2

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

  • Experimental

    Sequence 3

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(2)

  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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

12 results

Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial.

Kothare et al. 2012BMC clinical pharmacologycited by 23

PMID 22429273PMC3378442DOI 10.1186/1472-6904-12-8PUB-22429273

CC BY12 results
Download PDFSee results (12)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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