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

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ClinicalTrials.gov Identifier: NCT00504816
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: GSK189075 Drug: Brevicon Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Binovum

Arms and Interventions
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Arm Intervention/treatment
Brevicon
Oral contraceptive used to determine pharmacokinetics when given with GSK189075 to look for interaction.
 Drug: GSK189075
Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.
Experimental: GSK189075
Given in conjunction with Brevicon to see if GSK189075 interfered with Brevicon drug levels.
 Drug: Brevicon
Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Other Name: GSK189075


Outcome Measures
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Primary Outcome Measures :
  1. Oral contraceptive pill (OC) drug levels [ Time Frame: over 24h starting on Day 14 ]
  2. 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 :
  1. Adverse events [ Time Frame: all visits after study drug ]
  2. ECGs, Clinical laboratory tests [ Time Frame: screening & follow-up ]
  3. vital signs [ Time Frame: screening;Day 13, Period 1 & 3; Follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504816


Locations
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United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00504816    
Other Study ID Numbers: KG2107494
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: February 2011
Keywords provided by GlaxoSmithKline:
healthy female,
pharmacokinetics,
pharmacodynamics
drug interaction,
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Hormonal
Contraceptive Agents, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic