LIPT - Liraglutide in Polycystic Ovary Syndrome

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS. 70 women will be included in af RCT.

It had two arms (groups): Active (active comparator) and Placebo (placebo comparator).

Placebo s.c. daily for 26 weeks.

The registry classes the interventions as drug.

Who Took Part

72 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

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

Examples of who could join: BMI \>25 og 25 and thereunder + insulin resistent.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: actualt or intended pregnancy; inadeqvat contraception; hormonal contraception within 6 weeks.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-03 with completion listed for 2015-12.

It ran at 3 sites in Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Endogenous Thrombin Potential (ETP) (time frame: at time 0 and 26 weeks).

It also tracked 1 secondary outcome, for example Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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