- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504816
A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
May 31, 2012 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miramar, Florida, United States, 33025
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Brevicon
Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
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Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
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Experimental: GSK189075
Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.
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Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oral contraceptive pill (OC) drug levels
Time Frame: over 24h starting on Day 14
|
over 24h starting on Day 14
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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.
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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
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: all visits after study drug
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all visits after study drug
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ECGs, Clinical laboratory tests
Time Frame: screening & follow-up
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screening & follow-up
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vital signs
Time Frame: screening;Day 13, Period 1 & 3; Follow-up
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screening;Day 13, Period 1 & 3; Follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
July 13, 2007
First Submitted That Met QC Criteria
July 18, 2007
First Posted (Estimate)
July 20, 2007
Study Record Updates
Last Update Posted (Estimate)
June 4, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptives, Oral, Sequential
- Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Other Study ID Numbers
- KG2107494
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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