PCOSPhase 4NCT02187250
PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome
A Phase 4 study testing metformin, liraglutide and roflumilast in people with PCOS and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- What is being tested?
- metformin, liraglutide and roflumilast
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovenia
- Study dates
- Mar 2014to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30 kg/m² or higher
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- metformin, liraglutide, roflumilast
- Keywords
- PCOS, PDE-4 inhibitor, roflumilast, liraglutide, metformin, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
Also called Glucophage tablets
liraglutideDrug
Also called Victoza injection
roflumilastDrug
Also called Daxas 500 micrograms film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| metformin | Active comparator | 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. Receives: Drug: metformin |
| liraglutide | Active comparator | 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. Receives: Drug: liraglutide |
| roflumilast | Active comparator | In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os. Receives: Drug: roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome was change in body weight.
The patient's body weight was measured in kilograms.
Measured: Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.
Secondary outcomes (2)
The secondary outcome was change in body mass index (BMI).
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
Measured: 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.
Patient's waist circumference was measured in centimeters.
Measured: Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
- Investigators
- Andrej Janez, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187250
- Sponsor's protocol ID
- DAXAS 2
- Status last verified
- Jun 2014
- First submitted
- 8 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensterle M, Salamun V, Kocjan T, Vrtacnik Bokal E, Janez A. 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. J Ovarian Res. 2015 Jun 2;8:32. doi: 10.1186/s13048-015-0161-3.
PubMed 26032655
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02187250
- Acronym / sponsor ID
- DAXAS 2
- Keywords
- PCOS, PDE-4 inhibitor, roflumilast, liraglutide, metformin, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metformin | Active comparator | Drug: metforminIn 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. |
| liraglutide | Active comparator | Drug: liraglutideIn 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. |
| roflumilast | Active comparator | Drug: roflumilastIn the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30 kg/m² or higher
Key exclusion criteria (8 listed)
- depression
- type 1 or type 2 diabetes mellitus
- history of carcinoma
- history of pancreatitis
- Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metforminAlso: Glucophage tablets | Drug | metformin |
| liraglutideAlso: Victoza injection | Drug | liraglutide |
| roflumilastAlso: Daxas 500 micrograms film-coated tablets | Drug | roflumilast |
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.
The patient's body weight was measured in kilograms.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Derived from this study: PubMed 26032655Jensterle M, Salamun V, Kocjan T, Vrtacnik Bokal E, Janez A. 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. J Ovarian Res. 2015 Jun 2;8:32. doi: 10.1186/s13048-015-0161-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Janez, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metformin, liraglutide and roflumilast in people with PCOS and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02187250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.