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

July 8, 2014 updated by: Andrej Janez, University Medical Centre Ljubljana

Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: metformin
Other Names:
  • Glucophage tablets
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.
Drug: liraglutide
Other Names:
  • Victoza injection
ACTIVE_COMPARATOR: roflumilast
In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os.
Drug: roflumilast
Other Names:
  • Daxas 500 micrograms film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The patient's body weight was measured in kilograms.
Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
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.
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.
Patient's waist circumference was measured in centimeters.
Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The other outcomes was changes in fasting concentrations of glucose.
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in fasting concentration of insulin.
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in blood concentrations of LH (luteinizing hormone).
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in blood concentration of testosterone.
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in blood concentration in androstenedione.
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).
Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L.
Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (ESTIMATE)

July 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAXAS 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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