NCT01508858

Brief 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®).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 9, 2012

Last Update Submit

January 23, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • AUC of ethinylestradiol

  • AUC of levonorgestrel

Secondary Outcomes (5)

  • AUC (0-t)

  • Cmax, maximum concentration

  • tmax, time to reach Cmax

  • t½, terminal half-life

  • Adverse events

Study Arms (2)

Treatment period 1

EXPERIMENTAL
Drug: liraglutideDrug: placeboDrug: levonorgestrel / ethinylestradiol

Treatment period 2

PLACEBO COMPARATOR
Drug: liraglutideDrug: placeboDrug: levonorgestrel / ethinylestradiol

Interventions

liraglutideDRUG

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

Treatment period 1Treatment period 2
placeboDRUG

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

Treatment period 1Treatment period 2
levonorgestrel / ethinylestradiolDRUG

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

Treatment period 1Treatment period 2

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Uppsala, 75323, Sweden

Location

Related 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/dc13-1210. Epub 2014 Dec 12.

    PMID: 25504028RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

LiraglutideLevonorgestrelEthinyl Estradiol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 12, 2012

Study Start

November 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

SE(1)