Diabetes, Diabetes Mellitus, Type 2
Conditions
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 contraceptive drug (Neovletta®).
Interventions
DRUGliraglutide
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
DRUGplacebo
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
DRUGlevonorgestrel / ethinylestradiol
One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of ethinylestradiol | — |
| AUC of levonorgestrel | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, time to reach Cmax | — |
| AUC (0-t) | — |
| Adverse events | — |
| t½, terminal half-life | — |
| Cmax, maximum concentration | — |
Countries
Sweden
Outcome results
None listed