Status:
COMPLETED
Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
FEMALE
18-99 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contra...
Eligibility Criteria
Inclusion
- Postmenopausal woman
- Body Mass Index (BMI) between 18.0-30.0 kg/m\^2 (both inclusive)
- Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, blood and urinary laboratory assessments
Exclusion
- History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
- Impaired renal function
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunodeficiency virus) antibodies
- Known or suspected allergy to trial products or related products
- Pregnant or positive pregnancy test at screening or nursing mother
- Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®
- Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
- History of alcoholism or drug abuse
- Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
- Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01508858
Start Date
November 1 2006
End Date
April 1 2007
Last Update
January 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Uppsala, Sweden, 75323