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An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .

2014-08-27 03:15:35 | BioPortfolio

Summary

This study will be an open-label study to evaluate the effect of albiglutide on the pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.

Description

This study will be an open-label study in at least one center to evaluate the effect of albiglutide administration on the pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Healthy Female Volunteers

Intervention

Oral contraceptive (Brevicon), albiglutide

Location

GSK Investigational Site
Austin
Texas
United States
78744

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:35-0400

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Medical and Biotech [MESH] Definitions

Chemical substances or agents with contraceptive activity in females. Use for female contraceptive agents in general or for which there is no specific heading.

Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)

Contraceptive devices used by females.

Surveys that measure the usage rate of CONTRACEPTIVE DEVICES or CONTRACEPTIVE AGENTS.

A synthetic progestational hormone used often in mixtures with estrogens as an oral contraceptive.

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