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
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: ethinyl estradiol and levonorgestrel; exenatide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 38
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone
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 2
Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide
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 3
Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254800

Locations
United Kingdom
Research Site
Plymouth, United Kingdom
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00254800     History of Changes
Other Study ID Numbers: H8O-EW-GWBC
Study First Received: November 15, 2005
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
diabetes
exenatide
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Exenatide
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Hypoglycemic Agents
Incretins

ClinicalTrials.gov processed this record on October 01, 2014