The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

This study has been completed.

First Received: November 15, 2005 Last Updated: April 2, 2007 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	H8O-EW-GWBC
Study First Received:	November 15, 2005
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00254800 History of Changes
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
Contraceptive Agents
Amylin
Contraceptives, Oral
Diabetes Mellitus
Contraceptive Agents, Female

Endocrine System Diseases
Healthy
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Exenatide
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Diabetes Mellitus
Contraceptive Agents, Female

Endocrine System Diseases
Reproductive Control Agents
Pharmacologic Actions
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 02, 2009