Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women

Study Overview
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Brief Summary
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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®).

Official Title
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A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo
* Drug: levonorgestrel / ethinylestradiol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: liraglutide<br>* Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order<br>Drug: placebo<br>* Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order<br>Drug: levonorgestrel / ethinylestradiol<br>* One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period<br>|
| Placebo Comparator: Treatment period 2<br> | Drug: liraglutide<br>* Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order<br>Drug: placebo<br>* Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order<br>Drug: levonorgestrel / ethinylestradiol<br>* One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ethinylestradiol |  |  | 
| AUC of levonorgestrel |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-t) |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| t½, terminal half-life |  |  | 
| Adverse events |  |  |