The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254800
First received: November 15, 2005
Last updated: June 6, 2014
Last verified: June 2014

November 15, 2005
June 6, 2014
November 2005
August 2006   (final data collection date for primary outcome measure)
Evaluation of the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive [ 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 ] [ Designated as safety issue: Yes ]
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
  • Evaluation of the effect of exenatide on the single-dose pharmacokinetics of the combination oral contraceptive [ 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 ] [ Designated as safety issue: Yes ]
    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.
  • Assessment of the safety and tolerability of concomitant administration of exenatide and the combination oral contraceptive. [ Time Frame: Baseline through Day 84 ] [ Designated as safety issue: No ]
    Assessment of the safety and tolerability of concomitant administration of exenatide and the combination oral contraceptive by incidence of adverse events.
  • - 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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00254800
H8O-EW-GWBC
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

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