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

January 23, 2017 updated by: Novo Nordisk A/S

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

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®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75323
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
AUC of ethinylestradiol
AUC of levonorgestrel

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1330
  • 2006-003904-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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