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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508858
• Other study ID #: NN2211-1330
• Secondary ID: 2006-003904-21
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: January 23, 2017
• Start date: November 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
• placebo
Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
• levonorgestrel / ethinylestradiol
One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period

Locations

Country	Name	City	State
Sweden	Novo Nordisk Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of ethinylestradiol
Primary	AUC of levonorgestrel
Secondary	AUC (0-t)
Secondary	Cmax, maximum concentration
Secondary	tmax, time to reach Cmax
Secondary	t½, terminal half-life
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk