The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females - Full Text View

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

This study has been completed.

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00254800

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: exenatide	Phase I

MedlinePlus related topics:

Diabetes

Drug Information available for:

Exenatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics/Dynamics Study

Official Title:	The Effects of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	40
Study Start Date:	November 2005

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

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

Locations


United Kingdom
	Research Site
	Plymouth, United Kingdom

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators


Study Director:	James Malone, MD	Eli Lilly and Company

More Information

Study ID Numbers:	H8O-EW-GWBC
First Received:	November 15, 2005
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00254800
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes

exenatide

Amylin

Lilly

Study placed in the following topic categories:

Metabolic Diseases

Exenatide

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Healthy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008