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

What Was Tested

In this phase 1 trial, researchers set out to test 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®).

It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

21 actual participants took part.

It was open to women only aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: impaired renal function; active hepatitis b and/or active hepatitis c; positive hiv (human immunodeficiency virus) antibodies.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2006-11 with completion listed for 2007-04.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC of ethinylestradiol. AUC of levonorgestrel.

It also tracked 5 secondary outcomes, for example AUC (0-t), Cmax, maximum concentration, tmax, time to reach Cmax, t½, terminal half-life and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.