A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers

This study has been completed.

First Received: July 13, 2007 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00504816

Purpose

The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: GSK189075 Drug: Brevicon	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open Label, Single-Sequence, Repeat-Dose Study to Investigate the Effects of GSK189075 on the Pharmacokinetics of an Oral Contraceptive Pill When Coadministered to Healthy Female Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Modicon Ethinyl estradiol mixture with norethindrone Norinyl

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Oral contraceptive pill (OC) drug levels [ Time Frame: over 24h starting on Day 14 ]
blood hormone levels [ Time Frame: on Days 1, 11-14, & 21 of Periods 1 (OC alone) & 3 (OC plus GSK study drug). Period 2 is GSK drug study alone. ]

Secondary Outcome Measures:

ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ]
vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ]
Adverse events [ Time Frame: all visits after study drug ]

Estimated Enrollment:	20
Study Start Date:	April 2007

Eligibility

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

Criteria

Inclusion Criteria:

healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
able to take a specific oral contraceptive & KG2107494.
female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.

Exclusion Criteria:

pregnant or a nursing female.
female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
Have suffered with certain infection within 4 weeks prior to the first dose of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504816

Locations

United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	KG2107494
Study First Received:	July 13, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00504816 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

healthy female,
drug interaction,
pharmacokinetics,
pharmacodynamics

Study placed in the following topic categories:

Metabolic Diseases
Modicon
Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
Diabetes Mellitus
Endocrine System Diseases
Healthy

Norinyl
Contraceptives, Oral, Combined
Contraceptives, Oral, Sequential
Contraceptives, Oral, Hormonal
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Modicon
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Diabetes Mellitus
Contraceptive Agents, Female
Endocrine System Diseases
Reproductive Control Agents

Norinyl
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral, Sequential
Contraceptives, Oral, Hormonal
Therapeutic Uses
Diabetes Mellitus, Type 2
Contraceptives, Oral, Synthetic
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009