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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 13, 2007

Last Updated Date

October 9, 2008

Start Date ^†

April 2007

Current 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. ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00504816 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^†

Type 2 Diabetes Mellitus

Intervention ^†

Drug: GSK189075
Drug: Brevicon

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00504816

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.