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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01508858
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 9, 2012
January 9, 2012
November 2006
April 2007   (final data collection date for primary outcome measure)
  • AUC of ethinylestradiol [ Designated as safety issue: No ]
  • AUC of levonorgestrel [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • AUC (0-t) [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women
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®).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 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
  • Experimental: Treatment period 1
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
    • Drug: levonorgestrel / ethinylestradiol
  • Placebo Comparator: Treatment period 2
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
    • Drug: levonorgestrel / ethinylestradiol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01508858
NN2211-1330, 2006-003904-21
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
Novo Nordisk A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP