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OpenTrials
Completed

NCT Number: NCT01508858

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

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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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Uppsala, 75323, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Placebo

Drug

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

levonorgestrel / ethinylestradiol

Drug

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

Primary outcomes

  1. AUC of ethinylestradiol

  2. AUC of levonorgestrel

Secondary outcomes

  1. AUC (0-t)

  2. Cmax, maximum concentration

  3. tmax, time to reach Cmax

  4. t½, terminal half-life

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 12, 2012
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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