We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254800
First Posted: November 17, 2005
Last Update Posted: August 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
November 15, 2005
November 17, 2005
August 18, 2015
November 2005
August 2006   (Final data collection date for primary outcome measure)
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.
- 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.
Complete list of historical versions of study NCT00254800 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • - 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.
  • - To assess the safety and tolerability of concomitant administration of exenatide and the combination oral contraceptive.
Not Provided
Not Provided
 
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: ethinyl estradiol and levonorgestrel; exenatide
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
  • Experimental: Sequence 1
    Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone
    Intervention: Drug: ethinyl estradiol and levonorgestrel; exenatide
  • Experimental: Sequence 2
    Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide
    Intervention: Drug: ethinyl estradiol and levonorgestrel; exenatide
  • Experimental: Sequence 3
    Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide
    Intervention: Drug: ethinyl estradiol and levonorgestrel; exenatide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
August 2006
August 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00254800
H8O-EW-GWBC
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP