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PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome
Plain-language guide to NCT02187250: phase 4 randomized trial of Liraglutide, pcos, 45 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02187250
- Phase
- phase 4
- Status
- completed
- Start
- 2014-03
- Completion (planned or actual)
- 2014-06
- Participants
- 45 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- PCOS; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Liraglutide for pcos.
The investigators anticipated greater changes in body weight in patients on roflumilast treatment than in liraglutide or metformin.
It had three arms (groups): metformin (active comparator), liraglutide (active comparator) and roflumilast (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 45 actual participants took part.
It was open to women only aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 18 years old to menopause. Polycystic ovary syndrome (NICHD criteria). BMI of 30 kg/m² or higher.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus; history of carcinoma; history of pancreatitis.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
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.
Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2014-03 with completion listed for 2014-06.
It ran at 1 site in Slovenia.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): The main outcome was change in body weight (time frame: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial).
It also tracked 2 secondary outcomes, for example The secondary outcome was change in body mass index (BMI) and The secondary outcome was change in waist circumference.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 45 people with pcos.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, PCOS research.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.