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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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 13, 2007
Last updated: May 31, 2012
Last verified: February 2011
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 Diabetes Mellitus, Type 2 Drug: GSK189075 Drug: Brevicon Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

Enrollment: 22
Study Start Date: April 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its identifier: NCT00504816

United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00504816     History of Changes
Other Study ID Numbers: KG2107494
Study First Received: July 13, 2007
Last Updated: May 31, 2012

Keywords provided by GlaxoSmithKline:
healthy female,
drug interaction,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Contraceptive Agents
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 20, 2017