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Trial · Interventional

CompletedPhase 4Registry data

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

NCTNCT02187250 (opens ClinicalTrials.gov in a new tab)Other idDAXAS 2
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
45 participants (actual)
Sponsor
University Medical Centre Ljubljana · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Slovenia

Start
Mar 2014
Primary completion
Jun 2014
Completion
Jun 2014
First posted
10 Jul 2014 (estimated)
Last update posted
10 Jul 2014 (estimated)
Conditions
PCOS · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 4

    PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

    NCT02187250

    Mar 2014 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study was to determine whether monotherapy treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who have not been treated before. The investigators anticipated greater changes in body weight in patients on roflumilast treatment than in liraglutide or metformin.

Interventions

  • metforminDrug
  • liraglutideDrug
  • roflumilastDrug

Arms3

  • Active comparator

    metformin

    In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 2x1000 mg BID per os.

  • Active comparator

    liraglutide

    In the liraglutide group liraglutide was initiated at a dose of 0,6mg sc once per day for one week and increased to 1,2mg sc one per day.

  • Active comparator

    roflumilast

    In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    The patient's body weight was measured in kilograms.

Secondary outcomes(2)

  1. The secondary outcome was change in body mass index (BMI).

    Time frame · Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.

    Registry description

    Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.

  2. The secondary outcome was change in waist circumference.

    Time frame · Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

    Registry description

    Patient's waist circumference was measured in centimeters.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

7 results

Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.

Jensterle et al. 2015Journal of ovarian researchcited by 83

PMID 26032655PMC4506413DOI 10.1186/s13048-015-0161-3PUB-26032655

CC BY7 results
Download PDFSee results (7)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18 years old to menopause * polycystic ovary syndrome (NICHD criteria) * BMI of 30 kg/m² or higher Exclusion Criteria: * depression * type 1 or type 2 diabetes mellitus * history of carcinoma * history of pancreatitis * Cushing's syndrome or congenital (non-classic) adrenal hyperplasia * significant cardiovascular, kidney or hepatic disease * the use of medications other than metformin known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry

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