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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: levonorgestrel / ethinylestradiol; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01508858

2006-003904-21 (EudraCT Number)

NN2211-1330

Details and patient eligibility

About

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®).

Enrollment: 21 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Treatment period 1

Experimental group

Treatment:

Drug: levonorgestrel / ethinylestradiol

Drug: placebo

Drug: liraglutide

Treatment period 2

Placebo Comparator group

Treatment:

Drug: levonorgestrel / ethinylestradiol

Drug: placebo

Drug: liraglutide