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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

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®).

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment period 1

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order

placebo

Intervention Type DRUG

Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order

levonorgestrel / ethinylestradiol

Intervention Type DRUG

One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period

Treatment period 2

Group Type PLACEBO_COMPARATOR

liraglutide

Intervention Type DRUG

Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order

placebo

Intervention Type DRUG

Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order

levonorgestrel / ethinylestradiol

Intervention Type DRUG

One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period

Interventions

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liraglutide

Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order

Intervention Type DRUG

placebo

Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order

Intervention Type DRUG

levonorgestrel / ethinylestradiol

One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No